Clinical trials and or studies are an important way for us to learn more about GI Illnesses and help us find better treatment options. Participation in clinical studies or trials offers one way to help advance research into gastrointestinal (GI) disorders. Here is a list of clinical studies, in adults and children, that are seeking participants. A description of the study purpose and contact information is included.
Check out our Digestive Health Monthly eNewsletter for highlighted Clinical trials each month
Studies Looking At:
A
B
C
- Celiac Disease
- C. difficile infection
- Chronic Intestinal Pseudo Obstruction (CIPO)
- Coexisting Conditions
- Colorectal Cancer
- Congenital Sucrase-Isomaltase Deficiency (CSID)
- Covid-19
- Cyclic Vomiting Syndrome
D
E
F
G
- Gastroesophageal Reflux Disease (GERD)
- Gastroparesis
- Genetic Motility Disorders
- Gulf War Multisymptom Illness
- Gut microbiome
H
I
L
N
P
R
S
All GI Disorders
Added August 2024
Validation of a mental wellbeing scale for young people with chronic stomach symptoms
Purpose of Trial: The aim of this study is to validate a new mental wellbeing questionnaire in a group of young people aged 12-17 years with chronic stomach symptoms. Participation will involve completing a 15-minute online questionnaire, which is completely anonymous. This questionnaire will involve completing a series of questions asking about your general demographics, stomach symptoms, and mental health. At the end of the survey, you will be given the opportunity to go into the prize draw to have a chance at winning 1 of 2 $50NZD e-vouchers (which will be converted to your local currency).
Condition: Young people aged 12-17 years with chronic stomach symptoms.
Type of Study: Online, anonymous 15-minute survey.
Sponsor: The University of Auckland, New Zealand
Study Start Date: 16 July 2024
Study Completion Date: End of 2024
Participation
Inclusion Criteria:
To take part you must be 12-17 years of age and be able to read and write fluently in English. You must also experience chronic stomach symptoms, such as;
- Nausea/upset stomach
- Vomiting/throwing up
- Stomach pain, ache, or burning
- Feeling uncomfortably full or inability to finish a normal-sized meal
- Burping/belching or farting and a swollen stomach
- Food coming back up into your mouth
Or have been told you have any of the following conditions;
- Gastroparesis or delayed emptying
- Functional/chronic nausea
- Functional/chronic vomiting
- Cyclic vomiting syndrome
- Rumination syndrome
- Aerophagia
- Functional dyspepsia
Contact: Email Mikaela Law, m.law@auckland.ac.nz
NCT06394154
Added June 2024
Suicidal Thoughts and Behaviors Among Minoritized People with Disabilities
Purpose of study: My senior thesis aims to assess the impact of minority stressors such as stigma and discrimination on mental health and suicidal ideation in people with disabilities and chronic conditions.
Sponsor: N/A
Start date: June 2024
Completion date: November 2024
Participation
Inclusion Criteria:
- Identifying as a person with a disability or chronic condition
- Being 18 years of age or older at the start of the study
- Living in the United States
- Having access to the internet
Contact for study: Melissa Shang, melissashang@college.harvard.edu
Added April 2024
Correlation of Toxins With Gastrointestinal (GI) and Overall Health
Purpose of study: The goal of this observational study is to evaluate the levels of urinary environmental toxins, heavy metals, PFAS and mycotoxins with gastrointestinal (GI) and overall health.
Sponsor: Vibrant America Clinical Lab
Start date: March 2024
Completion date: February 2025
Participation
Inclusion Criteria:
- Patients suffering from gastrointestinal and/or other symptoms
- Patients willing to provide urine samples
- Patients willing to provide consent
Exclusion Criteria:
- Use of antibiotics 2 weeks prior to the study
- Patients unwilling to consent
Contact for study:
-
Hari K Krishnamurthy, MS, 866-364-0963, hari@vibrantsci.com
Added September 2023
Cross-sectional 12-year Trends of the Eating Behavior Survey
Purpose of Trial: The purpose of this cross-sectional study is to examine psychological well-being and eating behavior practices among young adults with and without diet-related chronic health conditions such as inflammatory bowel diseases, celiac disease, irritable bowel syndrome, type 1 or 2 diabetes, and cystic fibrosis. Condition: N/A Treatment or Intervention: no treatment- cross-sectional study
Sponsor: Rutgers University, School of Environmental & Biological Sciences
Inclusion Criteria: 18-30 years old
Start Date: January 2022
Completion Date: November 2023
Contact for Study: Virginia Quick, vquick@njaes.rutgers.edu
Added May 2023
GI Permeability Change in Response to Aquamin®
Purpose of study: This trial is being completed to learn about how Aquamin® affects gastrointestinal permeability, or the control of material passing from inside the gastrointestinal tract through the gut wall into the rest of the body, in people with ulcerative colitis (UC), Irritable Bowel Syndrome with diarrhea (IBS-D), and in healthy individuals.
Condition: Ulcerative Colitis (UC) and IBS-D
Sponsor: James Varani, University of Michigan
Study Start Date: November 2, 2021
Study Completion Date: December 2023
Participation: Each disease state has it’s own inclusion and exclusion criteria. You can view all here:
Contact for Study: Muhammad Nadeem Aslam 734-936-1897 mnaslam@umich.edu
Purpose of the study: To get perspectives from the GI patient community on disorders like irritable bowel syndrome, SIBO, and more. This survey takes approximately 5 minutes to complete.
Sponsors: Gemelli Biotech’
Start Date: April 2023
Contact: patientcare@triosmartbreath.com
Purpose of Trial: This phase III trial studies how well domperidone works in treating patients with gastrointestinal disorders. Domperidone may help control chronic gastrointestinal disorders and their symptoms, such as pain, bloating, and nausea and vomiting, by stimulating contraction of the stomach to increase its ability to empty itself of food.
Condition: FGIDs
Sponsor: M.D. Anderson Cancer Center
Collaborators: National Cancer Institute
Start Date: October 23, 2012
Completion Date: October 31, 2025
Participation:
- 16 years or older
-
Inclusion Criteria:
- Patients with GI disorders who have failed standard therapy
- Symptoms or manifestations of: a) gastroparesis; b) refractory gastroesophageal reflux disease (GERD) including persistent esophagitis, refractory heartburn, reflux-related laryngitis, and respiratory symptoms; or c) severe dyspepsia
- Completion of a comprehensive evaluation, including clinical history and physical examination, to eliminate other causes of their symptoms
- Patient has signed the informed consent document agreeing to the use of the study drug, domperidone
- White blood cell (WBC) with differential greater than 3,000/ml
- Alkaline phosphatase less than 1.5 x upper limit of normal
- Alanine aminotransferase (ALT) less than 2 x upper limit of normal
- Aspartate aminotransferase (AST) less than 2 x upper limit of normal
- Bilirubin less than or equal to 2 x upper limit of normal
- Blood urea nitrogen (BUN) less than 2 x upper limit of normal
- Creatinine less than 1.5 x upper limit of normal
- Stable hemoglobin greater than or equal to 8.0 g/dl
- Potassium between range of 3.0 to 5.5
- Magnesium level between 1.6-2.6 mg
Contact: Mehnaz Shafi 713-794-5073 mashafi@mdanderson.orgs
Added May 2022
Purpose of Study: To collect data and samples from people being seen and/or treated for gastrointestinal problems at NIH, to use in future research.
Sponsors: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Start Date: January 4, 2022
Competition date: December 31, 2035
Participation: See the Clinical Trials site for all inclusion and exclusion criteria
- 18 Years and older (Adult, Older Adult)
- Sexes Eligible for Study: All
- Accepts Healthy Volunteers: No
- Sampling Method: Non-Probability Sample
Contact:
- Beverly E Niles (301) 451-0659 beverly.niles@nih.gov
- Sheila Kumar, M.D. (301) 496-9730 sheila.kumar@nih.gov
Added June 2021
Purpose of Study: To learn more about the causes and effects of food allergy and related conditions.
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Participation: See study for all inclusion and exclusion criteria
- Be 2 to 99 years-old at the time of enrollment for participants who will be seen at the NIH CC; be 0 (newborn) to 99 years-old at the time of enrollment for participants who will submit mail-in samples or participate in telehealth visits. Only viable neonates will be enrolled.
- Willing to allow storage of blood, buccal swabs, saliva, nasal swabs, stool samples, and other clinically appropriate tissue specimens for future use in medical research
- Required to have a primary care or other physician who will manage all health conditions related or unrelated to the study objectives
Start date: July 29, 2015
Completion date: June 15, 2025
Contact: Caeden Dempsey by emailing at niaidfars@niaid.nih.gov
Added May 2021
Advanced Gastrointestinal Endoscopic Imaging
Purpose of Study: To develop new methods to detect malignant and premalignant conditions of the gastrointestinal tract
Sponsor: Stanford University
Completion Date: December 2025
Participation: See study for all inclusion and exclusion criteria
- patients be at least 18 years of age,
- Either genders
- All ethnic backgrounds will be considered.
- Patients who are scheduled for endoscopy by one of the investigators will be asked if they are interested in participating in the study.
- The study will be open to all patients undergoing endoscopy that do not have exclusion criteria.
- We will ask all patients if they are participating in any other studies. If they are participating in any other study then we will ask them for more information to determine whether there could be any harm from participating in both studies and if there is then they will not be enrolled.
Exclusion Criteria: Advanced Gastrointestinal Endoscopic Imaging
- Patients with unstable vital signs will not be included.
Contact:
- Cancer Clinical Trials Office (650)-498-7061 or email at ccto-office@stanford.edu
Purpose of study: The National Institute of Nursing Research (NINR), at the National Institutes of Health (NIH) is seeking people who are cancer survivors or have a chronic illness such as myalgic encephalomyelitis (ME), chronic fatigue syndrome (CFS), Sjogren’s disease, or Lupus to participate in a research study on fatigue. Fatigue is a common side effect of various illnesses. Researchers want to test if a one-time dose of the medication Ketamine or a similar drug can reduce fatigue. This is not a treatment study for fatigue, cancer, ME, CFS, Sjogren’s disease, or Lupus. Study procedures and medications are provided at no cost. Travel costs for study visits will be reimbursed in accordance with NIH guidelines.
Sponsor: National Institutes of Health (NIH)
Participation:
You may participate if you:
• Are at least 18 years old
• Have experienced fatigue for at least 6 months
• Are in cancer remission or have a diagnosis of ME, CFS, Sjogren’s disease, or Lupus
You may NOT participate if you:
• Have HIV, Hepatitis B, or C
• Have post-traumatic stress disorder (PTSD) or a traumatic brain injury
• Are pregnant or nursing
*Please note that NINR employees/staff or their immediate family members are not eligible to participate.
About the study:
• 9 visits to the NIH Clinical Center and 3 follow-up phone calls
• You will receive doses of Ketamine and an active drug (active placebo)
• You will complete questionnaires, assessments, and give blood samples
• This is an outpatient study that may last approximately one month
Contact:
NIH Clinical Center Office of Patient Recruitment
866-444-1132
Email: PRPL@cc.nih.gov
Added August 2019
Online Registry of Individuals with a Functional GI Disorder
Purpose of study: Participants sought for inclusion in a registry of individuals with functional GI disorders, in order to acquire a pool of individuals for contact for future studies.
Sponsor: Macquarie University, Australia
Participation: Any individual with a functional GI disorder and some level of abdominal discomfort is invited to participate.
About the study: Individuals included in the registry may be invited to participate in future research studies conducted by online questionnaire.
Contact: For more information, visit www.mqedu.qualtrics.com or email precise@mq.edu.au.
Added June 2020
Purpose of study: Doctors at the National Institutes of Health (NIH) seek healthy male volunteers, 18-35 years old with body mass index (BMI) of 18.5-25 kg/m2 to participate in the study. To calculate BMI visit: https://go.usa.gov/xUmyU. This study will collect data about the effects of currently approved anti-obesity drugs on your metabolic rate. Compensation provided to potential participants.
Sponsor: NIH
Completion Date: February 2024
Participation:
• Have a screening visit including medical history, physical exam, blood tests, and EKG
• Have six visits: (5) one-day overnight inpatient stays and (1) two–night overnight inpatient stay, over a six to twelve week period at the NIH Clinical Center.
• Stay in a temperature-controlled room and wear non-invasive devices to measure activity, heart rate, and temperature
• Receive daily study medications
You may not be eligible if you:
• Have high blood pressure or taking medications to control your blood pressure
• Have diabetes, liver disease, a thyroid condition, or heart disease
• Smoke or use tobacco products
For more information:
For more information:
NIH Clinical Center Office of Patient Recruitment
866-444-1132
800-877-8339 TTY / ASCII
Se habla español
Email: PRPL@cc.nih.gov
Online: https://go.usa.gov/xUmVp
NIH Study: 13-DK-0200
Amyloidosis
Added January 2022
Purpose of the study:
- Describe epidemiological and clinical characteristics, natural history and real-world clinical management of ATTR amyloidosis patients
- Characterize the safety and effectiveness of patisiran as part of routine clinical practice in the real-world clinical setting
- Describe disease emergence/progression in pre-symptomatic carriers of a known disease-causing transthyretin (TTR) mutation
Sponsor: Alnylam Pharmaceuticals
Start Date: November 23, 2020
Completion Date: December 2030
Participation: See study for all inclusion and exclusion criteria
- Child, Adult, Older Adult
- Male and female
- NOT Accepting healthy volunteers
Contact:
- Alnylam Clinical Trial Information Line 1-877-ALNYLAM clinicaltrials@alnylam.com
- Alnylam Clinical Trial Information Line 1-877-256-9526 clinicaltrials@alnylam.com
Covid-19
Coexisting Conditions
Purpose of trial: Elezanumab is an investigational drug being developed for the treatment of SCI. Elezanumab is a monoclonal antibody, that binds to an inhibitor of neuronal regeneration and neutralizes the inhibitor, thus potentially promoting neuroregeneration. This study is “double-blinded”, which means that neither trial participants nor the study doctors will know who will be given which study drug. Study doctors put the participants in 1 of 2 groups, called treatment arms. Each group receives a different treatment. There is a 1 in 3 chance that participants will be assigned to placebo. Participants 18-75 years of age with a SCI will be enrolled. Approximately 54 participants will be enrolled in the study in approximately 49 sites worldwide.
Participants will receive intravenous (IV) doses of elezanumab or placebo within 24 hours of injury and every 4 weeks thereafter through Week 48 for a total of 13 doses.
There may be a higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the course of the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
Sponsor: AbbVie
Start Date: Sept. 6, 2020
Completion Date: August 30, 2023
Participation:
- 18-75 years
- Male and Female
- Not accepting healthy volunteers
Inclusion Criteria:
- Acute traumatic cervical spinal cord injury (SCI), neurological level of injury of C4, C5, C6, or C7 with no damage to cord in thoracic (T2 and beyond) and lumbar regions that, in the investigator’s opinion, would significantly limit recovery.
- Maximum screening UEMS of 32.
- American Spinal Injury Association Impairment Scale (AIS) grade A or B at Screening.
- Able to initiate study drug administration within 24 hours of injury.
Contact: ABBVIE CALL CENTER 844-663-3742 abbvieclinicaltrials@abbvie.com
Study in Major Depressive Disorder With BTRX-335140 vs Placebo
Purpose of study: A proof of concept (POC) study evaluating the impact of BTRX-335140 relative to placebo on symptoms of major depressive disorder (MDD) in adult subjects with MDD and symptoms of anhedonia and anxiety following 8 weeks of double-blind treatment as assessed by the HAMD-17 Scale.
Sponsor: BlackThorn Therapeutics, Inc.
Start date: January 9, 2020
Completion date: June 2022
Participation:
- 18 to 65 years old
- Male and female
- Not accepting healthy volunteers
- See all inclusion and exclusion criteria here
Contact: Louis Wong (415) 912-9482 Louis.Wong@BlackThornrx.com
Barrett’s Esophagus
Added February 2024
Purpose of trial: This phase II trial studies the effect of obeticholic acid in treating patients with Barrett’s esophagus
Sponsor: National Cancer Institute (NCI)
Start date: July 2023
Completion date: August 2025
Participation: See website link below for all inclusion/exclusion criteria
- 18 and older
- All sexes
- Accepting Healthy Volunteers
Contact for study: Use link below to find contact for your location
Added June 2021
Purpose of study: The goal of this research is to determine the natural history of Barrett’s esophagus (BE) using tethered capsule endomicroscopy (TCE) in patients undergoing surveillance endoscopy.
Sponsor: Massachusetts General Hospital
Collaborators: National Institutes of Health (NIH) and National Cancer Institute (NCI)
Participation: (Check the website for more specific details on inclusion and exclusion criteria)
- Patients with known BE without high grade dysplasia, intramucosal adenocarcinoma or esophageal adenocarcinoma, confirmed by endoscopic biopsy,
- Patients over the age of 18
- Patients who are capable of giving informed consent
- Patients who had or will have a standard of care EGD within 9 to 15 months
- Subjects must have no solid food for at least 4 hours prior to the procedure, and only clear liquids for 2 hours prior to the procedure.
Start date: December 2016
Completion date: December 2023
Contact: Anna Gao, RN 617-643-6092 or email at Tearneylabtrials@partners.org
Contact: Anita Chung, RN 617-724-4515 or email at Tearneylabtrials@partners.org
Purpose of study: The goal of this research is to determine the natural history of Barrett’s esophagus (BE) using tethered capsule endomicroscopy (TCE) in patients undergoing surveillance endoscopy.
Sponsor: Massachusetts General Hospital, National Institutes of Health (NIH) and National Cancer Institute (NCI)
Participation:
Patients with known BE without high grade dysplasia, intramucosal adenocarcinoma or esophageal adenocarcinoma, confirmed by endoscopic biopsy,
Patients over the age of 18
Patients who are capable of giving informed consent
Patients who had or will have a standard of care EGD within 9 to 15 months
Subjects must have no solid food for at least 4 hours prior to the procedure, and only clear liquids for 2 hours prior to the procedure.
Contact: Anna Gao, RN 617-643-6092 Tearneylabtrials@partners.org
Contact: Anita Chung, RN 617-724-4515 Tearneylabtrials@partners.org
| NCT02947971 |
C. Difficile Infection (CDI)
Added December 2023
Prevention of Recurrent Clostridium Difficile Infection (CDI) in Patients With Inflammatory Bowel Disease (IBD)
Purpose of study: The study will compare the effectiveness of Bezlotoxumab in individuals with active C. diff ( Clostridium difficile) infection who are diagnosed with Inflammatory Bowel Disease.
Sponsor: University of Pittsburgh
Start date: 2021-10-30
Completion date: 2025-12-30
Participation:
- >18 years old
- active CDI receiving therapy
- diagnosis of IBD
- and history of CDI.
Contact:
- Claudia Ramos Rivers, 412-648-7402, cmr95@pitt.edu
- David Binion, 412-383-0571, cmr95@pitt.edu
Gastroesophageal Reflux Disease (GERD)
Added December 2023
Purpose of the study: This clinical feasibility study is to evaluate the performance of the Omega-Cuff in the treatment of acid reflux for up to 15 patients with a 1-year follow-up period. The Omega-shaped nitinol device is placed on top of the esophageal sphincter muscle just above the stomach in a laparoscopic surgical procedure without altering anatomy. In animal studies, the device safely increased the pressure on the sphincter, meaning it increased resistance to acid reflux, but did not interfere with normal food swallowing, meaning food went down to the stomach normally and smoothly. The device is intended to augment the function of the weak sphincter in minimizing acid reflux but allows easy swallowing of food in GERD patients. The clinical feasibility study is to see how well this device functions in patients and to assess its safety profile. This is a permanent implant that will last the lifetime of the patient. The device will not interfere with patients who may need diagnostic MRI scans. The device can be safely removed if needed.
Sponsor: Aplos Medical
Collaborators:
- National Institutes of Health (NIH)
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Start date: August 2023
Completion date: March 2025
Participation:
-
Subject must be at least 22 years of age and must be less than 75 years of age with a life expectancy > 3 years.
- Subject is a suitable surgical candidate, i.e., is able to undergo general anesthesia and laparoscopic surgery.
- Subject has documented typical symptoms of gastroesophageal reflux disease (GERD) for longer than 6 months (regurgitation or heartburn that is defined as a burning epigastric or substernal pain that responds to acid neutralization or suppression).
- Subject requires daily proton pump inhibitor or other anti-reflux drug therapy.
- Total Distal Ambulatory Esophageal pH must meet the following criteria: pH< 4 for ≥ 4.5% of the time Note: Subjects will have discontinued any GERD medications for at least 10 days prior to testing.
- Subject has a symptomatic improvement on proton-pump inhibitor (PPI) therapy demonstrated by a GERD-Health-Related Quality of Life (GERD-HRQL) score of ≤ 10 on proton-pump inhibitors and ≥ 15 off PPIs, or subjects with a ≥ 6-point improvement when comparing his/her on-PPI and off-PPI GERD-HRQL score.
- Subject has GERD symptoms in absence of PPI therapy (minimum 10 days).
- If the subject is of child-bearing potential, she must have a negative pregnancy test within one week prior to implant and must agree to use effective means of birth control during the course of the study.
- Subject is willing and able to cooperate with follow-up examinations.
- Subject has been informed of the study procedures and the treatment and has signed an informed consent form.
Contact: Claude Tihon, 1-952-944-3749, claude@aplosmed.com
Added September 2023
Purpose of study: This early phase I trial studies the guanylyl cyclase C (GCC) agonist effect on cGMP signal in duodenal tissue. Plecanatide and linaclotide are drugs approved by the Food and Drug Administration for the treatment of conditions related to constipation. This trial aims to see the effects of taking either one of two drugs, plecanatide or linaclotide, or no drug, on a certain chemical found in the tissue collected from small intestine and how they compare.
Sponsor: National Cancer Institute (NCI)
Start date: 2022-10-25
Completion date: 2025-02-01
Participation:
- Scheduled for clinically indicated esophagogastroduodenoscopy (EGD)
- Age >= 18 years of age. Note: Because no dosing or adverse event (AE) data are currently available on the use of plecanatide or linaclotide in participants < 18 years of age, children are excluded from this study but will be eligible for future pediatric trials, if applicable
- Willing to provide mandatory biospecimens as specified in the protocol
- Eastern Cooperative Oncology Group (ECOG) performance status =< 1
- Not pregnant or breastfeeding, as determined by clinical administration of pregnancy test prior to EGD procedure. Note: The effects of plecanatide and linaclotide on the developing human fetus at the recommended therapeutic dose are unknown. For this reason, women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for 2 weeks after discontinuing study agent. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her study physician immediately. Breastfeeding should be discontinued if the mother is treated with plecanatide or linaclotide
- Ability to understand and the willingness to sign a written informed consent document
Contact: Visit link below to find contact for your location
Minimally Invasive Surgery of the Gastro-esophageal Junction (MISGEJ)
Purpose of study: This study will assess short and long term outcomes of individuals undergoing minimally invasive surgery of the gastro-esophageal junction (MISGEJ). Patients will respond to questionnaires on an annual basis evaluating quality of life and functionality following MISGEJ. Hospital charts will also be reviewed on an annual basis to assess patient health outcomes.
Sponsor: Ottawa Hospital Research Institute
Participation: All patients undergoing minimally invasive surgery of the gastro-esophageal junction at the Ottawa Hospital.
Contact: Andrew JE Seely, MD, PhDOttawa Hospital Research Institute https://clinicaltrials.gov/
Functional Heartburn
**Currently no active studies**
Rumination Syndrome
**No active clinical trials
Gastroparesis
Added June 2024
Exploring brain fog, fatigue, psychological distress and the impact on quality of life for those living with gastroparesis
Purpose of study: While it is known that psychological distress and poor quality of life are common problems in individuals living with gastroparesis, the role of brain fog and fatigue are less known. This research aims to understand how brain fog and fatigue impact psychological distress and quality of life.
Sponsor: nil
Start date: July 2024
Completion date: October 2024
Participation:
- We are looking for both male and female participants that self-identify as having been diagnosed with gastroparesis, and who are at least 18 years of age. Participants must be able to give informed consent and be competent in the English language
Contact:
- Associate Professor Simon Knowles (Swinburne University of Technology, Associate Professor and Clinical Psychologist, (03) 9214 8206,sknowles@swin.edu.au
To participate, please click on the study URL here: https://swinuw.au1.qualtrics.com/jfe/form/SV_cVbmynmfwy3Dk7s
Added December 2023
Purpose of study: The purpose of this research is to evaluate the 12-month treatment effect of peroral endoscopic pyloromyotomy (G-POEM) vs. sham surgery in patients with gastroparesis that is not helped by medications and to analyze factors that may predict the outcome of the surgery.
Sponsor: Mayo Clinic
Start date: July 2023
Completion date: July 2025
Participation:
- Symptoms of chronic nausea or vomiting compatible with gastroparesis (idiopathic or diabetic) must be present for at least one year (does not have to be contiguous) prior to registration.
- Must have a mean total Gastroparesis Cardinal Symptom Index (GCSI) score of ≥ 3 at screening visit.
- Refractory gastroparesis, defined using our previously published data5, as a failure to improve over the last 6 months, despite an adequate trial of one or more standard prokinetics (metoclopramide, erythromycin, prucalopride), antinauseants (5-HT3 antagonists, promethazine, prochlorperazine, dronabinol), or neuromodulators (mirtazapine, buspirone).
- Moderate to severe delay in gastric emptying, defined as > 25% solid retained at 4 hours or > 75% retained at 2 hours. The qualifying gastric emptying scintigraphy must be performed within 18 months prior to registration or can be the baseline gastric emptying.
- No evidence of mechanical obstruction based on upper GI endoscopy or upper GI series in their medical history.
Contact:
- Irene Busciglio, 507-266-6615, Busciglio.irene@mayo.edu
- Guillermo Barahona, 480-301-4238, Barahona.Guillermo@mayo.edu
Added April 2023
A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of CIN-102 (Deudomperidone) in Adult Subjects With Diabetic Gastroparesis
Purpose of Trial: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of CIN-102 (Deudomperidone) in Adult Subjects With Diabetic Gastroparesis
Condition: Diabetic gastroparesis
Treatment or Intervention: Treatment
Sponsor: CinDome Pharma, Inc.
Start Date: March 31, 2023
Completion Date: October 23, 2024
Participation:
- Is a male or female ≥18 years of age;
- Has a diagnosis of Type 1 or Type 2 diabetes, according to the American Diabetes Association criteria;
- Has a current diagnosis of diabetic gastroparesis defined by the following:
- Gastrointestinal symptoms felt to be consistent with gastroparesis within 6 months prior to Screening; AND
- Documented delayed gastric emptying within the past 2 years or willing to complete a gastric emptying breath test.
- Body mass index (BMI) between 18 and 45 kg/m2, inclusive;
- Glycosylated hemoglobin (HbA1c) level <10% at Screening;
- Willing to washout from ongoing treatment for gastroparesis.
Contact for Study: Rachael Farley R.Farley@Medpace.com, +1.513.579.9911, ext. 11961
Added August 2022
Purpose of Trial: To conduct a dose-ranging, sham-controlled trial () to assess the effect of Thoracic Spinal Nerve Magnetic Neuromodulation Therapy (ThorS-MagNT) on symptom severity and quality of life in diabetic gastroparesis.
Condition: Diabetic gastroparesis
Treatment or Intervention: Thoracic Spinal Nerve Magnetic Neuromodulation Therapy (ThorS-MagNT)
Sponsor: National Institute of Diabetes and Digestive and Kidney Disease
Study Start Date: July 1, 2022
Study Completion Date: June 30, 2025
Participation:
Inclusion Criteria:
- Outpatient diabetic gastroparesis patients with refractory symptoms and total ANMS GCSI score ≥ 2.0;
- Men or women age less than 85;
- No known mucosal disease;
- Speak, write, and understand English (by self-report);
- On stable doses of any medication for 30 days prior to entering the study and do not to change medications or dosages during the study period.
Exclusion Criteria:
- Postsurgical gastroparesis or prior gastric surgery (fundoplication, gastric resection or pyloroplasty);
- Gastrointestinal obstruction, Achalasia, Chronic Intestinal Pseudo-obstruction, Colonic Inertia;
- Use of opioids greater than 3 times a week and marijuana more than 5 times a week;
- Change in neuromodulator dosage in last 3 months (TCA, gabapentin, olanzapine, etc.) or use of sympathomimetics;
- Seizure history or disorder, Severe, unstable cardiac disease and arrythmias, Renal failure/dialysis;
- Metal implants that are not MR safe, gastric electrical stimulators (GES), deep brain stimulators (DBS), sacral nerve stimulators (SNS), or pacemakers;
- Pregnant women or nursing mothers;
Contact for Study:
Augusta University Contact info:
- Amol Sharma, MD, MS
Augusta University
Phone: 706-721-2239
Email: amosharma@augusta.edu
Massachusetts General Hospital Contact Info:
- Braden Kuo, MD, MS
Mass General Gastroenterology
Phone: 617-726-2426
Email: BKUO@mgh.harvard.edu
Added May 2022
GI Neuromuscular Pathology Prospective Registry
Purpose of Study: In this research study, biopsy samples will be collected to provide more insight into the underlying cause of the motility disorders, help direct further investigation into the cause of the underlying condition, provide future prognosis and predict response to gastric electrical stimulation (GES).
Sponsors: Indiana University
Start Date: December 2013
Competition date: December 2025
Participation: See the Clinical Trials site for all inclusion and exclusion criteria
- 6 Months to 90 Years (Child, Adult, Older Adult)
- Eligible for Study: All
- Accepts Healthy Volunteers: Yes
- Sampling Method: Non-Probability Sample
Contact:
- Contact: Travis Putzke 317-278-2064 tputzke@iu.edu
Contact: Kara Murphy 317-278-0406 clarkara@iu.edu
Added January 2022
Purpose of the Study: A randomized clinical trial comparing endoscopic per-oral pyloromyotomy (POP) versus a control sham intervention (diagnostic esophagogastroduodenoscopy (EGD) without pyloric disruption) in patients with medically refractory gastroparesis.
Sponsor: The Cleveland Clinic
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Start Date: February 2022
Completion Date: July 2026
Participation: See study for all inclusion and exclusion criteria
- 18 to 65 years of age
- All sexes
- NOT accepting healthy volunteers
Contact:
- Denise Rose 216 445-4523 ROSED2@ccf.org
Added May 2021
Magnetic Resonance Imaging of the Brain and Stomach in Healthy Volunteers and Gastroparesis
Purpose of the Study: The study is to lay the groundwork for non invasive imaging of the GI tract and the brain gut interaction
Sponsor: Indiana University School of Medicine
Start date: 2/14/2020
Completion Date: 12/31/2025
Participation:
If Healthy Patient
- Healthy volunteers from 18 to 65 years of age
If Gastroparesis Patient:
- Patients with gastroparesis from 18 to 65 years of age.
- Symptoms of gastroparesis of at least 12 weeks duration with varying degrees of nausea, emesis, early satiety, effortless regurgitation, post-prandial fullness and pain, and/or postprandial epigastric pain.
- Abnormal 4-hour gastric emptying scintigraphy within the last 6 months >60% retention at 2 hrs and/or >10% retention at 4 hrs.
Contact:
- Anita Gupta, MBBS, MPH (317) 948-9227 or email at anigupta@iu.edu
- Fred Hermann (317) 278-9293 or email at fhermann@iu.edu
Added January 2019
Purpose of study: This is a single-center, randomized pilot study to be conducted at Massachusetts General Hospital. The purpose of this study is to examine the non-pharmacological impact of Cognitive Behavioral Therapy (CBT) on gastroparesis symptoms and other clinical co-comorbidities such as pain, depression, anxiety, and catastrophizing. A subset of the CBT trial patients will undergo careful phenotyping pre- and post- intervention with brain MRI, autonomic function test (AFT), gastric emptying scintigraphy (GES), wireless motility capsule test (WMC), and nutrient drink test (NDT) to determine the impact of CBT on these metrics in patients with gastroparesis. Patients randomly assigned to a standard medical treatment (SMT) group will be treated by the standard of care. Characterization of these relationships or lack thereof can help guide future development of more targeted approaches and optimize treatment strategies for gastroparesis.
Sponsors: Massachusetts General Hospital
Participation:
Male and female patients aged 18 – 65 years old (inclusive)
Symptoms of gastroparesis of at least 12 weeks duration (do not have to be continuous) with varying degrees of nausea, vomiting, early satiety, and/or post-prandial fullness
An idiopathic etiology
GES of solids using 4 hours Egg Beaters® protocol within the last 6 months with either:
– Abnormal gastric emptying rate defined as an abnormal 2 hour (>60% retention) and/or 4 hour (>10% retention) result based on a 4 hour scintigraphic low fat Egg Beaters® gastric emptying study.
Body mass index (BMI) ≥ 17.5 kg/m2
Have not previously received CBT for coping with chronic illness
Have access to a computer with internet access
Speak, write, and understand English
On stable doses of any medication for 30 days prior to entering the study (exceptions are psychotropic, opioids, and/or illicit drugs) and agrees not to change medications or dosages during the study period.
Contacts: For mor information, please visit: https://clinicaltrials.gov/
Contact: April Mendez 617-726-0196 amendez5@mgh.harvard.edu
Added April 2020
Purpose of study: To study an investigational drug to help symptoms for Diabetic Gastroparesis.
Sponsors: UNC Center for Esophageal Diseases and Swallowing.
Participation: Do you have Diabetic Gastroparesis? (i.e. : nausea, abdominal pain, post-prandial fullness, bloating, vomiting, and early satiety) If you are at least 18 years of age and currently suffering from symptoms of Diabetic Gastroparesis, you may be eligible for a research study involving an investigational drug to help reduce these symptoms. Study participation could last as long as 12-weeks. Compensation may be included for eligible participants.
Contacts: If you are interested in learning more about this study, please call (919) 843-0821 or email Ariel_Watts@med.unc.edu.
Added January 2019
Purpose of study: To evaluate the efficacy of tradipitant relative to placebo in change from baseline to in nausea severity and other symptoms of gastroparesis.
Sponsors: Vanda Pharmaceuticals
Participation: Diagnosed with idiopathic or diabetic gastroparesis with moderate to severe nausea and delayed gastric emptying.
Contacts: Jesse Carlin Jesse.Carlin@vandapharma.com. For more information, please visit gpvandastudy.com
Added January 2020
Purpose: Researchers are trying to determine if subjects with diabetic gastroparesis and symptoms of bloating will have a greater improvement in bloating symptoms when treated with rifaximin.
Sponsors: Mayo Clinic
Study Population: Men and women adult patients, aged 18-75, with diabetic gastroparesis
Diagnosis of diabetic gastroparesis will have been made previously using a combination of symptoms (e.g., nausea, vomiting, bloating, early satiety, abdominal pain), the absence of mechanical obstruction, and delayed gastric emptying using a 4-hour, solid phase scintigraphic study (GES; > 20% remaining at 4 hours)
Contact information: For more information, please visit https://clinicaltrials.gov/
Contact: Brian Lacy, MD 904-953-2000 lacy.brian@mayo.edu
Contact: Cangemi David, MD 904-953-2000 cangemi.david@mayo.edu
Verified September 2020
Purpose: To create a national prospective registry of children and adolescents with gastroparesis and gastroparesis-like syndrome (symptoms of gastroparesis but normal gastric emptying) to include demographic, clinical, psychological, nutritional characteristics, physiological measures, and serial assessments of symptoms over 3 years during their clinical care; to establish a biorepository of plasma, serum, peripheral blood mononuclear cells (PBMC), GI mucosal biopsies (in those undergoing upper GI endoscopy), urine and stool collected from the children and adolescents in this registry which will allow for future analyses such as cytokines, bacterial DNA and microbiome to investigate the etiology and pathogenesis of gastroparesis in children.
Sponsors: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study Population: 1.) Cardinal symptoms of gastroparesis of at least 12 weeks duration. Cardinal symptoms of gastroparesis are the constellation of some combination of: nausea, vomiting, early satiety, postprandial fullness; symptoms sometimes may be accompanied by upper abdominal pain; 2.) An etiology of either diabetic, idiopathic, or post-fundoplication gastroparesis or gastroparesis-like disorder (symptoms of gastroparesis but normal gastric emptying; see below); 3.) Gastric emptying scintigraphy (GES) of solids using the 4-hour Egg Beaters® protocol (or equivalent generic liquid egg white meal) within the last 6 months with either: a.) Abnormal gastric emptying rate defined as an abnormal 2-hour (>60% retention) and/or 4-hour (>10% retention) result based on a 4-hour scintigraphic gastric emptying study. (This group will comprise ~75% of patients in the registry) or b.) Patients with a normal gastric emptying rate, but who have symptoms of gastroparesis. (This group will comprise ~25% of patients in the registry); 4.) Age at least 5 years, and under 18 years at initial screening visit
Contact information: Laura Miriel laura.miriel@jhu.edu, or for more information visit here
Rare Genetic Diseases
**No active Clinical Trials
Non-Alcoholic Fatty Liver Disease
Added June 2023
Purpose of study: In non-alcoholic fatty liver disease (NAFLD), fat accumulates in the liver and can cause damage. Researchers want to learn what causes the damage NAFLD, and to see if a medication can help.
Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Start date: July 24, 2019
Completion Date: August 1, 2024
Participation:
- Male or female Aged >= 18 years of age.
- Histological evidence of hepatic steatosis on a liver biopsy within 12 months OR evidence of fatty liver disease, as documented by imaging (ultrasound, CT, MRI, MRI-PDFF, MR spectroscopy, or Fibroscan CAP >= 285 db/M25) within 12 months.
- Estimated average alcohol consumption < 30 g/d for men or < 20 g/d for women in the 6 months prior to enrollment and no binge-drinking behavior.
- Ability of subject to understand and the willingness to sign a written informed consent document.
Contact: Yaron Rotman, M.D. (301) 451-6553 rotmanyaron@mail.nih.gov
Pediatric Gastrointestinal
Added June 2024
Purpose of Trial: There are no current, approved therapies to treat children 2 to 5 years of age with functional constipation (FC). Therefore, this study is designed to assess the safety and efficacy of an investigational drug in pediatric patients ages 2 to 5 years of age with functional constipation.
Sponsor: AbbVie
Study Start Date: December 22, 2022
Study Completion Date: November 14, 2025
Condition or Disease State: Pediatric Functional Constipation
Participation:
a. Are between 2 and 5 years and 11 months old.
b. Have a history of painful or hard bowel movements.
c. Meet additional study criteria.
Contact for Study:
If you are interested in this study for your child, please talk to your doctor and complete the online screener to see if your child qualifies for this study: https://pediatric-constipation-study.com/PAG/
To learn more about this study, please visit: https://www.clinicaltrials.gov/study/NCT05652205
Added April 2024
Purpose of Trial: To evaluate the safety and efficacy of once daily oral plecanatide for 4 weeks as treatment for the relief of symptoms associated with IBS-C in children ages 6 to < 18 years.
Sponsor: Bausch Health
Study Start Date: Ongoing
Study Completion Date: 31 Dec 2024
Condition or Disease State: Irritable Bowel Syndrome with Constipation (IBS- C)
Participation:
Inclusion Criteria:
- must be 6 to <18 years old
- male or female
- meets the Rome IV criteria for IBS-C (For at least 2 months, abdominal pain the occurs at least 4 days per month and associated with one or more of the following: defecation, a change in frequency of stool, and/or change in form [appearance] of stool.)
Exclusion Criteria:
- One loose or watery stool in the absence of laxative use within 14 days prior to randomization
- diagnosis of irritable bowel syndrome with diarrhea (IBS-D) or irritable bowel syndrome mixed (IBS-M)
- medical history or condition that may affect GI motility or defecation
- lack of willingness to use Dulcolax as the only laxative during the study
- non-compliance with diary and rescue medication use.
Contact for Study:
Locations:
This study is being conducted in 10 states – Alabama, Arizona, California, Colorado, Florida, Georgia, Iowa, Louisiana, Nebraska, and Texas at multiple sites
If you would like to participate, use this link https://bit.ly/3xjsrCo to select a location and provide your contact information. You will be contacted by someone from the site you selected to further determine if you qualify for the study.
Added January 2024
Purpose of Trial: Are you a parent with IBS? Consider joining the REACH Study! The purpose of this paid research study is to test whether an online program can help parents with irritable bowel syndrome (IBS) teach their young children to develop healthy habits.
Sponsor: Seattle Children’s Hospital, University of Washington
Condition: IBS
Start date: October 2023
Completion date: 2027
Participation:
Parents/caregivers meeting the following criteria may be a good fit for REACH:
- Have irritable bowel syndrome (IBS) or chronic unexplained abdominal pain
- Have children between 4 and 7 years of age in their household
- Able to speak, read and understand English
What will participants be asked to do?
- Complete online lessons for about 4 weeks (20-30 minutes per week)
- Complete 5 online surveys (45-60 minutes each), spread over a period of about 1.5 years
All study tasks done remotely. Study treatments are provided at no cost. Families will be compensated for their time (up to $325 total in Amazon gift cards).
Contact for study: Click here to fill out interest form! https://redcap.link/reach-kids
Application of Pharmacogenomics in Choosing Antidepressants for Children suffering from stress-induced IBS
Purpose of Trial: Graduate thesis
Condition: Stress induced IBS
Start date: Jan 9th, 2024
Completion Date: March 4th, 2024
Contact for Study: Tripta Rughwani
IRB File # EXP452781
Link to survey: Take survey here
Added December 2023
Purpose of study: The goal of this investigator-initiated, single-center, randomized controlled trial (RCT) is to compare the effects of four weeks of three therapies on clinical and mechanistic outcomes based on pH-Imp testing using a three-arm parallel design in NICU infants with objective GERD diagnosis. The three therapies being compared are natural maturation, proton pump inhibitor (PPI) use, and added rice (AR) formula use.
Sponsor: Nationwide Children’s Hospital
Collaborators:
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Start date: November 2023
Completion date: November 2027
Participation:
-
NICU infants of any gestational age who are between 37 – 47 weeks postmenstrual age at inception of the study meeting the following requirements:
- GERD diagnosis using pH-impedance criteria (Acid Reflux Index ≥ 3% plus at least one of the following: # GER events >70 / day, Symptom Associated Probability ≥ 95%, Discal Baseline Impedance < 900 Ω)
- Full enteral feeds
- No current GERD therapies
Contact:
- Erika K Osborn, 614-355-6667, erika.osborn@nationwidechildrens.org
- Patty Luzader, 614-355-6667, patty.luzader@nationwidechildrens.org
Added November 2023
Purpose of Trial: To assess the Safety and Efficacy of Tenapanor for the Treatment of IBS-C in adolescents.
Condition: IBS-C
Treatment or Intervention: Tenapanor 25 mg bid, or 50 mg bid or placebo
Phase of Trial: 3
Sponsor: Ardelyx, Inc
Study Start Date: November 2022
Study Completion Date: Aug 2024 (end of enrollment)
Participation:
Inclusion Criteria:
- ≥12 and <18 years old
- Patient weighs ≥18 kg at the time the patient provides written assent
- Females of child-bearing potential must have negative pregnancy test at Visit 1 (serum) and Visit 2 (urine) and confirm the use of appropriate contraception (including abstinence).
- Patient meets the Rome IV criteria for child/adolescent diagnosis of IBS-C
- Patient is willing to discontinue any laxatives used in favor of the protocol-permitted rescue medicine (which will only be allowed after 72 hours with no bowel movement)
- Patient meets the entry criteria assessed during the 2-week Screening period.
- Ability of both the patient and parent/guardian/LAR to communicate with the Investigator and to comply with the requirements of the entire study, including an understanding of the assessments in the eDiary and how to use the eDiary device
- Patient must provide written assent and the parent/guardian/LAR must provide written informed consent before the initiation of any study-specific procedures
Exclusion Criteria:
- Functional diarrhea as defined by Rome IV child/adolescent criteria
- IBS with diarrhea (IBS-D), mixed IBS (IBS-M), or unsubtyped IBS as defined by Rome IV child/adolescent criteria
- History of non-retentive fecal incontinence.
- Required manual disimpaction any time prior to randomization (after consent);
- Has both unexplained and clinically significant alarm symptoms (lower gastrointestinal [GI] bleeding [rectal bleeding or heme-positive stool], iron-deficiency anemia, or any unexplained anemia, or weight loss) and systemic signs of infection or colitis, or any neoplastic process
- Patient has any of the following conditions:
- Celiac disease, or positive serological test for celiac disease
- Cystic fibrosis
- Hypothyroidism that is untreated or treated with thyroid hormone
- Down’s syndrome or any other chromosomal disorder
- Active anal fissure
- Anatomic malformations (eg, imperforate anus)
- Intestinal nerve or muscle disorders (eg, Hirschprung disease)
- Neuropathic conditions (eg, spinal cord abnormalities)
- Lead toxicity, hypercalcemia
- Neurodevelopmental disabilities producing a cognitive delay that precludes comprehension and completion of the daily eDiary (Electronic handheld device)
- Inflammatory bowel disease
- Childhood functional abdominal pain syndrome
- Childhood functional abdominal pain;
- Poorly treated or poorly controlled psychiatric disorders that might influence his or her ability to participate in the study;
- Lactose intolerance that is associated with abdominal pain or discomfort
- History of cancer other than treated basal cell carcinoma of the skin; (Note: Patients with a history of cancer are allowed provided that the malignancy has been in a complete remission for at least 5 years before the Randomization Visit.)
- History of diabetic neuropathy.
- Use of medications that are known to affect stool consistency (Prohibited Medications), including fiber supplements, anti-diarrheals, cathartics, antacids, opiates, prokinetic drugs, laxatives, enemas, antibiotics during the Screening period; unless specified as rescue medication, and used accordingly as directed by the Investigator.
- Patient has had surgery that meets any of the following criteria:
- Bariatric surgery for treatment of obesity, or surgery to remove a segment of the GI tract at any time before the Screening Visit;
- Surgery of the abdomen, pelvis, or retroperitoneal structures during the 6 months before the Screening Visit;
- An appendectomy or cholecystectomy during the 60 days before the Screening Visit;
- Other major surgery during the 30 days before the Screening Visit
- History of alcohol or substance abuse
- Participation in other clinical trials within 1 month prior to Screening
- Patient and/or parent/guardian/LAR is involved in the conduct and/or administration of this trial as an investigator, sub-investigator, trial coordinator, or other staff member, or the patient is a first-degree family member, significant other, or relative residing with one of the above persons involved in the trial
- If, in the opinion of the Investigator, the patient is unable or unwilling to fulfill the requirements of the protocol or has a condition, which would render the results uninterpretable
Contact for Study: jtabora@ardelyx.com
Purpose of Trial: Irritable Bowel Syndrome with diarrhea (IBS-D) is a digestive disorder that can cause abdominal pain, bloating, gas, frequent loose stools or a combination of the above. IBS-D occurs in people of all ages, including children.
This study is being conducted to evaluate the safety and efficacy of an investigational medication, eluxadoline, for treating pediatric patients with IBS-D, ages 6-11 years old.
Condition: IBS-D
Treatment or Intervention: Eluxadoline
Phase of Trial: II
Type of Study: Dose selection study
Sponsor: Abbvie, Inc
Inclusion Criteria: Your child may qualify if they:
- Are 6 to 11 years of age
- Have frequent episodes of diarrhea
- Are in generally good health
- Meet additional study criteria
Study Start Date: November 2017
Study Completion Date: TBD
Contact for Study:
- Interested participants: https://pediatric-ibsd.researchstudytrial.com/
- healthcare providers: https://peds-ibsd-hcp.researchstudytrial.com/
ABBVIE CALL CENTER 844-663-3742 abbvieclinicaltrials@abbvie.com
NCT003339128
Body Surface Gastric Mapping (BSGM) to Evaluate Patients With Gastrointestinal (GI) Symptoms
Purpose of Trial: The goal of this observational study is to learn about gastric myoelectric activity in children with GI symptoms. The main question it aims to answer is which patterns or signals are associated with GI symptoms as measured by a body surface gastric mapping (BSGM) device. Participants will have their stomach activity recorded for up to 4 hours using the BSGM device and log real-time symptoms. Researchers will compare the recordings of healthy children and children with GI symptoms to define abnormal GI patterns.
Sponsor: Children’s Hospital of Philadelphia
Conditions: Functional GI Disorders, Gastrointestinal motility disorders, Dyspepsia and other specified disorders of function of stomach, gastroparesis
Start Date: 10-1-2021
Completion date: 12-31-2024
Inclusion Criteria:
- Male or female age 8-25 years
- Confirmed diagnosis of a functional gastrointestinal and/or motility disorder by Rome IV criteria
- Body mass index of < 35
- Females ≥11 years of age or who have reached menarche must have a negative urine pregnancy test and must use an acceptable method of contraception for the duration of the study
- Parental/guardian permission (informed consent) and if appropriate, child assent
Contact: Children’s Hospital of Philadelphia, Hayat Mousa MD, MousaH@chop.edu
Added September 2023
Feasibility, Safety, and Potential Efficacy of Fecal Microbiota Transplantation (FMT) for Gastrointestinal Dysfunction in Children Following Hematopoietic Cell Transplant (HCT)
Purpose of study: Participants will be eligible to receive an FMT on or after Day +30 post-HCT. FMT will be performed using FMP material obtained from OpenBiome. 60 mL of FMP will be administered via NJ tube and 250 mL via colonoscopy. A second FMT may be performed at least 14 days after the initial FMT in GI clinical symptoms have partially improved or have not changed. The second FMT will be administered using the same procedure as in the initial FMT
Sponsor: St. Jude Children’s Research Hospital
Start date: September 2023
Completion date: December 2024
Participation:
- Age < 22 years old.
- Received an allogeneic HCT greater than or equal to 30 days prior to enrollment
-
Diagnosed with one of the following conditions:
- Steroid-resistant gut a GvHD (defined as GI symptoms that do not improve within 5 days after initial steroid therapy, >/= 1mg/kg of prednisolone) OR
-
Steroid-dependent gut a GvHD (defined as the presence of a response to methylprednisolone 2 mg/kg/day but relapsing when an attempt was made to taper steroid treatment).
OR
-
Current or prolonged GI dysfunction following HCT, defined as having diarrhea or loose stools >/= 4 weeks with at least one of the following:
- Requiring NG or G-tube feeds
- Requiring TPN or IVF for more than 4 weeks
- Diagnosis of gastroparesis by GI specialist documented in the medical record
- Willing and able to provide informed assent/consent
Contact: Gabriela Maron, MD 866-278-5833, referrainfo@stjude.org
Added July 2023
Study to Assess the Efficacy and Safety of NEXIUM for Maintenance of Healing of Erosive Esophagus(EE)
Purpose of Study: Esomeprazole (NEXIUM™) is indicated for the maintenance of healing of endoscopy-verified erosive esophagitis (EE) in children 1 to 11 years of age in a number of countries worldwide, but not in the United States (US). The current study has been designed, in discussions with the Food and Drug Administration (FDA), to further evaluate the safety and efficacy of NEXIUM given as maintenance of healing of EE in children 1 to 11 years of age
Sponsor: AstraZeneca
Start Date: July 2022
Completion Date: August 2026
Participation:
- Patient must be 1 to 11 years of age
- Patients must have a history of GERD for at least 3 months before the start of study
- For the healing phase: Patients must have confirmed presence of EE at endoscopy performed within one week of the start of the healing phase.
- For the maintenance phase: Patients must have completed the healing phase and have endoscopy-verified healed EE at the 8-week endoscopy visit.
- Patients must weigh ≥ 10 kg.
- Patients may be male or female.
- All postmenarcheal female patients must have a negative pregnancy test (urine) before starting treatment.
- Sexually active patients must be abstinent or maintain effective contraception from informed consent day up to the last day of IMP treatment.
- Patient’s guardian must be capable of giving signed informed consent
Contact: AstraZeneca Clinical Study Information Center, 1-877-240-9479, information.center@astrazeneca.com
Added November 2022
Purpose of Trial: The investigators propose that using a Clinical Decision Support System (CDSS) that incorporates the Rome IV criteria for diagnosis and evidence-based care for FGIDs will improve the (1) accuracy of diagnosis and (2)_ effectiveness of clinical care. A CDSS has advantages with respect to guideline adherence and automated diagnosis, because it can provide focused, real-time, patient-specific data to the clinician. The investigators hypothesize that automation of screening, diagnosis, and management of FGIDs using the Rome IV criteria will result in improved resolution of FGIDs (primary outcome), as well as decreased utilization of medical services (secondary outcomes). This hypothesis will be tested utilizing a randomized controlled trial. The intervention clinic sites will be provided access to both the FGIDs Screening Module and the Treatment Module. The control clinics will have the FGIDs Screening Module. However, control clinics will not have access to the FGIDs Treatment Module. These clinic sites will be given access to the pre-screener form section of the module, so that providers are made aware of a positive screen.
Condition: FGIDs
Sponsor: Indiana University and NIDDK
Start Date: November 2021
Completion Date: January 2024
Participation:
- 1-17 years old
- Any patient between the ages of 0 through 17 presenting to a pediatric primary care clinic in the Eskenazi health system and the Primary Care Physician who sees them
Contact: William E Bennett, MD 317-944-3774 webjr@iu.edu
Purpose of Trial: The purpose of this study is to determine the safety, efficacy, and pharmacokinetics (PK) of etrasimod for the treatment of moderately to severely active ulcerative colitis in adolescents (≥ 12 years up to < 18 years of age). Participants who will complete the total 52-week treatment period will have the opportunity to continue in a Long-Term Extension (LTE) Period of up to 4 years (5 years after study enrollment), or until marketing authorization is obtained in the participant’s country, whichever comes first.
Condition: Ulcerative Colitis
Sponsor: Arena Pharmaceuticals
Start Date: November 2022
Completion Date: January 2025
Participation:
- 12-17 years old
Inclusion criteria:
- Have a diagnosis of ulcerative colitis (UC) that is moderately to severely active
- Participants are permitted to be receiving a therapeutic dose of select UC therapies
Exclusion criteria:
- Severe extensive colitis
- Diagnosis of Crohn’s disease (CD) or indeterminate colitis or the presence or history of a fistula consistent with CD
- Diagnosis of microscopic colitis, ischemic colitis, or infectious colitis
Contact: Arena CT.gov Administrator +1 855-218-9153 ct.gov@arenapharm.com
Purpose of Trial: The purpose of this study is to explore the outcomes, tolerability and safety of 2 different doses of oral pantoprazole (full healing dose, half healing dose), assigned based upon weight, for the maintenance of healing of erosive esophagitis in pediatric participants aged 1 to 17 years with endoscopically-confirmed, healed erosive esophagitis.
Condition: Esophagitis
Sponsor: Pfizer Pharmaceuticals
Start Date: January 2022
Completion Date: December 9, 2027
Participation:
- 1-17 years old
Inclusion Criteria:
- Participants must have a documented erosive lesion with an Los Angeles (LA) Grade of A to D prior to starting Proton Pump Inhibitor treatment:
- Capable of giving signed informed consent/assent
- Willingness and ability of the participant or parent/legal guardian to complete the eDiary
- Willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures, including the use of the eDiary.
- Male and female participants aged 1 to 17 years.
- Minimum body weight 7 kilogram and weight at least at the 5th percentile per the Center for Disease Control standard age and weight chart, for the participant’s age.
- To be considered a female of non childbearing potential, the participant must meet at least 1 of the following criteria :
- Premenarchal: The investigator (or other appropriate staff) must discuss the participant’s premenarchal status with the participant and parent/legal guardian at office visits and during telephone contacts, as participants who achieve menarche during the study would no longer be considered “female participants of non childbearing potential” and must comply with the protocol requirements applicable to women of childbearing potential.
Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com
Celiac Disease
Added February 2023
Purpose of study:
A clinical trial to evaluate ZED1227 in comparison with placebo in subjects with celiac disease experiencing symptoms despite gluten-free diet
Sponsor: Dr. Falk Pharma GmbH
Phase of Trial: Phase IIB
Completion date: Ongoing
Participation:
Inclusion:
- Documented diagnosis of celiac disease proven by biopsy at least 12 months prior to screening
- Adherence to a gluten-free diet (GFD) for at least 12 months prior to screening
- Human leukocyte antigen DQ (HLA-DQ, a type of genetic testing) typing compatible with celiac disease
- At least one moderate or severe gastrointestinal symptom (i.e., diarrhoea, abdominal pain, bloating or nausea) during the last 4 weeks prior to first study visit
- Negative diagnosis of Helicobacter pylori (H pylori) infection
Exclusion:
- Selective immunoglobulin A deficiency
- Diagnosis of confirmed refractory celiac disease type I or II (exception: RCD I can be considered for inclusion if there is no clear sign of T cell monoclonality or atypical T cells)
- Severe complications of celiac disease
- Any concomitant diseases of the intestinal tract in addition to celiac disease
- Evidence of relevant systemic disease
EudraCT Number: 2020-004612-97
Study website: Contact for study
Added January 2023
Purpose of study: To evaluate the efficacy of TAK-062, as measured by the CDSD, for reducing celiac-related symptoms due to gluten exposure in subjects with CeD attempting to maintain a GFD in treated subjects versus placebo controls.
Sponsor: Takeda
Phase of Trial: Phase IIB
Start date: June 2022
Completion date: June 2025
Participation: See all inclusion and exclusion criteria here
- Age 12-75 Years old
- Has an adequate comprehension of a GFD assessed by completion of a knowledge test after viewing of educational materials.
- Has at least 1 CeD-related GI symptom of moderate or greater severity, as measured by the CDSD, on at least 3 days out of any consecutive 7-day period during the screening period (Week -8 visit until Week -4 visit), felt by the investigator to be related to gluten exposure. The CeD-related symptom(s) may vary day by day as long as the severity of at least 1 symptom is moderate or greater. The participants must meet symptom criteria to undergo esophagogastroduodenoscopy (EGD)/video capsule endoscopy (VCE).
Has been attempting to maintain a GFD for at least 12 months as self-reported by the participant. - Has small intestinal villous atrophy on duodenal biopsy defined as Vh:Cd <2.5 at Week -4.
The participant is human leukocyte antigen (HLA)-DQ2 and/or HLA-DQ8 positive.
The participant is in a good general state of health according to clinical history and physical examination, in the opinion of the investigator.
Have a body mass index (BMI) between 16 and 40 kilogram per meter square (kg/m^2), inclusive. - The participant is willing and able to continue any current dietary and/or medical regimens (including gastric acid suppression) in effect at the first visit (Visit 1).
Study website: https://illuminatecd.com/
Contact:
- +1877-825-3327 medinfoUS@takeda.com
Chronic Intestinal Pseudo-Obstruction
Added February 2024
Pseudo-Obstruction Assessment With MRI (POM)
Purpose of study: This study will explore the potential for a standardized MRI scan after a liquid meal to be used in diagnosis of the rare but debilitating chronic intestinal pseudo-obstruction (CIPO).
Sponsor: University of Nottingham
Start date: 1/17/2020
Completion date: 12/20/2024
Participation:
- 16 years or older
- Ability to give informed consent
- Sufficient level of English language to understand study information and respond to symptom questionnaires
- CASES: a clinical diagnosis of primary or secondary Chronic Intestinal Pseudo-Obstruction, excluding adhesional obstruction. PICs will be asked to send clinical documentation that the diagnosis has been confirmed on crosssectional imaging.
- CONTROLS: a Chronic constipation disorder diagnosed according to Rome IV criteria for functional constipation, constipation-predominant irritable bowel syndrome or opioid-induced constipation (diagnostic criteria as listed in Lacy et al 2016)
Contact for study:
-
Giles Major, PhD, +44 115 8231035, giles.major@nottingham.ac.uk
Irritable Bowel Syndrome (IBS)
Added September 2024
Purpose of Trial: The purpose of this research is to research the relationship between menstruation and gastrointestinal symptoms. We will be using a free smartphone app, called Clue Period Tracker & Calendar in our study. We will be recruiting healthy controls, and patients diagnosed with Irritable Bowel syndrome (IBS), and chronic idiopathic constipation (CIC). The study will assess the use of used a menstrual cycle app in order to track menstrual cycle phases in IBS and CIC, and its link with symptom severity.
Condition or Disease State: Irritable Bowel Syndrome, Chronic Idiopathic Constipation
Study Start Date: 10/16/2023
Study Completion Date: N/A
Participation:
Inclusion Criteria:
- Premenopausal females with IBS, CIC, or healthy controls, aged 18 to 40 years of age, regular menses, have not had pregnancy or childbirth within the previous 12 months. All subjects must have access to a smartphone.
- Premenopausal females with IBS: The diagnosis of IBS and bowel habit subtypes (IBS with diarrhea [IBS-D], IBS with constipation [IBS-C], IBS with mixed bowel habits [IBS-M]) will be based on the ROME IV diagnostic criteria for IBS and no evidence of organic GI disease.
- Premenopausal females with CIC: The diagnosis of CIC will be based on the ROME IV criteria for CIC, and no evidence of organic GI disease.
- Premenopausal female healthy controls: No current or past history of chronic GI or pain disorders. All subjects must have access to a smartphone.
Exclusion Criteria:
- Females who have had a bilateral oophorectomy and/or hysterectomy, use of oral contraceptive agents (OCP) or hormone replacement therapy (HRT), current pregnancy, childbirth within the past 12 months, history of active psychiatric illness.
Contact for Study: Regan Cortessis (rcortessis@mednet.ucla.edu)
Purpose of Trial: The purpose of this research is to study sex differences in Irritable Bowel Syndrome (IBS) related to the brain and gut microbiome, and the impact of a 12-week modified cognitive behavioral therapy (CBT) on the brain and gut bacteria health.
Sponsor: NIH
Condition or Disease State: Irritable Bowel Syndrome, Chronic Idiopathic Constipation
Study Start Date: 06/29/2020
Study Completion Date: N/A
Treatment or Intervention: 12-week Cognitive Behavioral Therapy program using Mahana Research App
Participation:
Inclusion Criteria:
- Premenopausal females and males with IBS symptoms, aged 18 to 50 years of age, have not had pregnancy or childbirth within the previous 12 months, not currently being treated by GI specific CBT. All subjects must have access to a smartphone.
- The diagnosis of IBS and bowel habit subtypes (IBS with diarrhea [IBS-D], IBS with constipation [IBS-C], IBS with mixed bowel habits [IBS-M]) will be based on the ROME IV diagnostic criteria for IBS and no evidence of organic GI disease.
Exclusion Criteria:
- hormone replacement therapy (HRT), current pregnancy, childbirth within the past 12 months, history of active psychiatric illness, any major chronic diagnosis (cancer, diabetes, IBD, celiac disease etc)
Contact for Study: Juliana Reist (jreist@mednet.ucla.edu)
Added May 2024
Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Parallel-Group Study to Evaluate the Efficacy, Safety, and Tolerability of CIN-103 in Adults with Irritable Bowel Syndrome With Predominant Diarrhea (IBS-D)
Purpose of Trial: To evaluate if the study drug can help reduce the symptoms associated with irritable bowel syndrome with predominant diarrhea (IBS-D) in adult patients
Sponsor: CinPhloro Pharma, LLC
Condition: IBS-D
Start date: December 28, 2023
Completion date: December 11, 2024
Participation:
Key Inclusion Criteria:
- Are adult male and female subjects ≥18 years of age
- Have a body mass index between 18 and 40 kg/m2, inclusive at screening
- Meet Rome IV Criteria for IBS-D by subject self-report of recurrent abdominal pain that is associated with ≥2 of the following over the last ≥6 months, with frequency of at least 1 day per week over the last 3 months (on average) before enrollment
Key Exclusion Criteria:
- Have a diagnosis or suspected diagnosis of non-diarrhea predominant IBS (eg, IBS with a subtype of constipation, IBS with mixed or alternating bowel habits, un-subtyped IBS) or functional constipation by the Rome IV Criteria;
- Have a history of or current inflammatory bowel disease
- Have a known family history of inflammatory bowel disease in at least 1 first-degree relative
Contact: www.envivastudy.com
Added June 2023
Changes in Microbiota and Quality of Life in IBS
Purpose of study: The primary research question to be addressed is: Does a 2′-FL-containing dietary supplement impact stool microbiota composition in adults with IBS? The primary measure for determining potential impacts of the 2′-FL-containing dietary supplement on stool microbiota composition is stool abundance of Faecalibacterium prausnitzii, a commensal intestinal bacteria. Additional measures related to determining potential impacts of the 2′-FL-containing dietary supplement on gut microbiota composition are stool levels of additional commensal intestinal bacteria and measures of intestinal microbial diversity.
Sponsor: National University of Natural Medicine
Start Date: April 2022
Completion Date: December 31, 2023
Participation:
- All genders
- Adults over 18 to 70 years old
- Existing diagnosis of IBS
- Willing to take the 2′-FL-containing dietary supplement (or a control supplement) three times per day for 6 weeks
- Willing to attend 4 in-person study visits
- Willing to collect 3 stool samples at home
- Willing to periodically monitor stool form/consistency (and log the information on a diary)
- Willing to complete IBS symptom focused questionnaires
- Willing to refrain from making changes in dietary supplements and medications for the duration of the study
- Willing to maintain current dietary pattern for the duration of the study
- Willing to maintain current exercise pattern for the duration of the study
- Able to speak, read, and understand the English language
- Able to provide written informed consent
Contact: Anders Gundersen, MS 503-552-1752 agundersen@nunm.edu
Added April 2022
Purpose of the study: In the largest and most well-controlled randomized control trial of mindfulness-based interventions (MBIs) training in irritable bowel syndrome (IBS) to-date (N=325), the investigators will evaluate whether a smartphone MBI program (with attention monitoring and acceptance skills training; Monitor+Accept, MA-MBI) reduces daily life stress and IBS symptoms at post-treatment and two-month follow-up, relative to a matched MBI program with acceptance skills training removed (training in attention monitoring skills only; Monitor Only, MO-MBI) or to an active stress management training control group (Coping Control, CC). Participants will not only provide clinician and patient assessed measures of IBS symptoms at the three time points, but they will also provide sensitive experience sampling assessments (using Ecological Momentary Assessment) of their stress and symptoms in daily life at each time point. Finally, as an exploratory aim, participants will provide stool samples at baseline and post-intervention to provide the first ever test of whether MBIs can alter the gut microbiome in IBS.
Sponsor: Carnegie Mellon University
Collaborators: National Institutes of Health (NIH) and National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Start Date: February 10, 2022
Completion Date: September 2025
Participation:
- Rome IV IBS diagnosis
- Indicate moderate to high levels of psychological distress over the past two weeks (composite score >5 on the Patient Health Questionnaire-4)
- Willingness to provide assessments of bowel symptoms and complete study measures (including smartphone assessments)
- Willingness/availability to be randomized and participate in all study activities
Contact: J. David Creswell, Ph.D. 412-268-9182 creswell@cmu.edu
Added March 2022
Lifestyle Eating and Performance (LEAP) Program for the Treatment of Irritable Bowel Syndrome (IBS)
Purpose of study: Primary Objective:
- To evaluate the effectiveness of the LEAP program to improve cytokines levels for 3 months of treatment in participants with IBS.
Secondary Objective(s):
- To evaluate the effectiveness of the LEAP program to improve gastrointestinal symptoms for 3 months of treatment in participants with IBS.
- To evaluate the effectiveness of the LEAP program to improve in quality of life for 3 months of treatment in participants with IBS.
Condition: Irritable bowel syndrome (IBS)
Treatment or Intervention: Lifestyle Eating and Performance (LEAP) program is a multiphase tailored eating plan that is methodically prepared for individuals with irritable bowel syndrome. Foods for each phase are selected based on the degree of Leukocyte Activation Assay-MRT (LAA-MRT®) reactivity, starting with the least immune reactive foods, and subsequent foods will be added in a nutritionally balanced manner.
Phase of Trial: Phase IV
Sponsor: Oxford Biomedical Technologies, Inc.
Start Date: September 2021
Completion Date: September 1, 2022
Participation:
- Ages Eligible for Study: 18 Years to 75 Years (Adult, Older Adult)
- Sexes Eligible for Study: All
- Accepts Healthy Volunteers: No
Inclusion Criteria:
- Adult patients (age 18-75 years);
- Established diagnosis of IBS as determined by Rome III or IV Criteria;
- Have IBS of at least moderate severity [score on the IBS-SSS of > 175 (0-500) at the baseline visit];
- Patients will be allowed to be taking medications or supplements at the initial visit, but they must be on a stable dose regimen for at least 1 month prior to enrolment;
- Willing to follow the LEAP program for 3 months;
- Able to give informed consent and willing to complete the study.
Visit https://www.nowleap.com/research/IBSStudy and fill out the participation request form.
Contact:
-
IBS Study Team – Oxford Biomedical Technologies (561) 848-7111 ext. 714 ibsstudy@nowleap.com
Added February 2022
Atlantia-Human Milk Oligosaccharides (HMOs) for Irritable Bowel Syndrome (IBS) (HIBS)
Purpose of the Study: HMO mix has been shown to provide therapeutic benefits to individuals with IBS of all subtypes (Palsson et al., 2019). DSM is planning this trial in order to investigate if clinically relevant improvements in bowel movements and IBS symptoms can be obtained through the use of the HMO mix in individuals with moderate to severe IBS and abdominal pain.
Eligible participants will have a diagnosis of Irritable Bowel Syndrome (IBS). Participants will be assessed for eligibility at the screening visit, must meet all the inclusion criteria, and none of the exclusion criteria.
In this trial, participants will be randomized to one of two intervention groups (a Human Milk Oligosaccharide mix or placebo) and receive intervention for at least 12 weeks.
Sponsor: DSM Nutritional Products, Inc.
Start Date: January 1, 2022
Completion Date: January 2024
Participation: See study for all inclusion and exclusion criteria
- 18 years or older
- All sexes
- No healthy volunteers
Contact: (312) 535-9440 or volunteers@atlantiatrials.com or visit https://atlantiaclinicaltrials.com/chicago/study/ibs-study for more information
Stress and Health-Related Quality of Life Among Adults with IBS
Purpose of the Study: To research the effects of stress, pain, thinking, interpersonal relationships, and quality of life. The researcher specifically wants to learn the relationship with the levels of stress when performing tasks at home or at work, pain, anxiety, interpersonal relationships, and the overall quality of life with symptoms of irritable bowel syndrome (IBS)
Participation:
- English-speaking adults between the ages of 18 to 65 years old and suffer from irritable bowel syndrome (IBS)
Research conducted by: Aida Benitez-Rexach, Master of Philosophy in Psychology student at Walden University and doctoral student, under the supervision of Dr. M. Hanania and Dr. D. Heretick of Walden University.
To participate: Please fill out this survey
05-19-21-035615
Added April 2021
A Randomized, Double-Blind, Technology-Enabled Trial to Evaluate the Impact of a Multi-Strain Synbiotic (DS-01) on Metagenomic Stability and Metabolic Output of the Gut Microbiota.
Purpose of Study: This study aims to assess the impact of multi-strain consortia of 24 commensal organisms across 12 species with extensive strain-specific in vivo data, assessing a range of gastrointestinal symptoms without negatively altering the naive gut microbiota. High-throughput shotgun DNA sequencing will provide an opportunity for ‘-omics’-based analyses of the gut microbiota, which can be augmented by the metabolite profiles resulting from total microbial activity in the gut. Since many of these metabolites are bioeffector molecules acting upon the host, such analysis can provide a direct measure of the consequences of microbial activity in the gut and provide a novel integrated data set for patients with IBS. Recruited subjects will also use a smart-phone application to report day to day gastrointestinal symptoms, a patient-centric hallmark of this chronic gut condition.
Sponsor: Beth Israel Deaconess Medical Center
Condition: Irritable bowel Syndrome-Constipation (IBS-C) and Irritable Bowel Syndrome-Mixed (IBS-M)
Participation:
- Patient must be willing and able to give informed assent/ consent for participation in the study (see Section 15.2).
- Patient must be willing and able (in the PI’s opinion) to comply with all study requirements.
- Patient must be a premenopausal female aged 18 and older.
- Patient must have a documented history of IBS that is not completely controlled by current IBS drugs.
- Patient must have a score of ≥150 on the IBS-SSS at screening.
- Patient must have no clinically relevant (in the judgment of the PI) abnormal blood laboratory levels at screening or randomization.
- The clinician will assess eligibility as per the Rome IV criteria (Recurrent abdominal pain or discomfort at least 1 day/week in the last 3 months associated with two or more of the following: Improvement with defecation. Onset associated with a change in frequency of stool).
Study Contact: For more information, call Vivian Cheng, MS, MPH at (617)-667-0682, or Email: vcheng2@bidmc.harvard.edu
Added May 2018
Participants Sought for Study on Complementary Approaches to the Treatment of IBS
Purpose of study: The purpose of this study is to find a complementary treatment to help Irritable Bowel Syndrome (IBS) patients in need of relief.
About The Study: The length of this study will be three weeks long, with a short online intervention everyday to help individuals deal with their body’s reactions to their environments. Participants will have additional surveys to assess their overall state at the beginning of the study, at the end of the three week intervention, and again at six weeks for a follow-up.
Participation: Eligible individuals between the ages of 18 – 65 years of age who are experiencing pain or discomfort associated with their gut. Cannot be smokers or have an inflammatory bowel disease.
How to Sign Up:http://bit.ly/IBS_study
There will be a $15 Target gift card for first 30 participants upon completion of study.
Study Contact: Jenna N. Ray, Health Psychologist. Phone: (919) 257 – 7291, Email: jray51@uncc.edu
Congenital Sucrase-Isomaltase Deficiency (CSID)
Evaluation of a 7-Day Therapeutic Trial Dose of Commercial Sucraid®(sacrosidase) Oral Solution for Alleviating Congenital Sucrase-Isomaltase Deficiency (CSID) Symptoms in Pediatric Subjects with Low, Moderate, and Normal Sucrase Levels
Purpose of Trial: To investigate the effects of Sucraid® treatment on gastrointestinal symptoms in subjects with low, moderate, and normal disaccharidase assay sucrase levels from an esophagogastroduodenoscopy (EGD).
Treatment or Intervention: Commercial Sucraid®
Sponsor: QOL Medical
Study Start Date: May 2022
Study Completion Date: March 2024
Participation:
Inclusion Criteria:
1. Subjects with documented disaccharidase assay levels of lactase, sucrase, maltase, and palatinase via EGD disaccharidase assay (DA) performed no more than 1 year prior to enrollment with normal histological interpretation. Eligible subjects will be enrolled into the following study groups based on their documented sucrase level.
- DA Sucrase <25 µM/min/gram protein (N=500)
- DA Sucrase 25-35 µM/min/gram protein (N=500)
- DA Sucrase >55 µM/min/gram protein (N=100)
2. At the discretion of the investigator, subject is suspected of CSID and has at least one symptom of diarrhea, abdominal pain, gas/bloating, nausea, or borborygmi at least 3X per week for the past 3 months or more.
3. Subject or parent/guardian must provide informed consent/assent prior to any study procedures being performed.
4. Subject is a U.S. resident.
5. Subject is male or female; ages 6 months to 17 years old at the time of screening.
6. Subject/parent or guardian is willing and able to complete necessary study procedures including following study instructions, completing electronic questionnaires via a personal mobile device, attending study visits and, in the Investigator’s judgement is sufficiently able to participate in the study.
7. Subject/parent or guardian must be able to reach or understand the English language.
8. Subject or parent/guardian must have their own Android or Apple device for Bring Your Own Device patient mobile app (BYOD).
Contact for Study: Nathalie Chan Director, Patient Recruitment Services Nchan@totalcro.com
Inflammatory Bowel Disease (IBD)
Added May 2023
Purpose of Study: The purpose of this study is to collect clinical data and samples (including blood, breath and stool) donated by patients with IBD and patients with no IBD (controls) to facilitate research that may result in the development of new non-invasive methods of diagnosing IBD and understand the progression of the disease over time in order to better manage IBD patients.
Sponsor: AbbVie
Start Date: March 22, 2021
Completion Date: April 30, 2024
Participation:
Inclusion Criteria:
- Diagnosed as having Crohn’s Disease or Ulcerative Colitis
- Aged 18-70 years.
- Understands the language and signs an informed consent form.
- Any disease location, except isolated upper GI Crohn’s disease only
- Any CD or UC disease activity.
- Outpatients and inpatients
- Patients will be recruited, and samples obtained at least one day, and no more than one week, prior to out/inpatient colonoscopy preparation to allow objective assessment of disease activity.
Contact: Ronald Ottichilo 2163727109 ottichr@ccf.org
Added January 2023
Purpose of study: To study the use of Darvadstrocel in the treatment of complex perianal fistulas occurring in pediatric CD population
Sponsor: Takeda
Phase of Trial: Phase III
Start date: June 2021
Completion date: January 2024
Participation: See all inclusion and exclusion criteria here
- Has a CD diagnosis based on accepted clinical, endoscopic, histological and/or radiologic criteria at least 6 months before the screening visit.
- Has complex perianal fistula refractory to at least one of the following treatments: immunosuppressants or biologics (anti-TNFs, anti-integrin, anti-interleukin [IL] 12/23). Fistula(s) refractory to therapy is defined in this study as follows: Immunosuppressants: Inadequate response after 3 months, based on clinical assessment, or more treatment with azathioprine, 6-mercaptopurine or methotrexate. Biologics: Inadequate response after 14 weeks (16 weeks for anti-IL 12/23), based on clinical assessment, or more standard treatment for induction and maintenance.A complex perianal fistula(s) that meets one or more of the following criteria, modified from the American Gastroenterological Association (AGA) technical review: High intersphincteric, transsphincteric, extrasphincteric, or suprasphincteric as assessed by MRI. Presence of 2 or 3 external openings (tracts) as assessed by clinical examination. Associated fluid (abscess) collections as determined by MRI.
Contact:
- +1877-825-3327 medinfoUS@takeda.com
Purpose of study: To study the use of Vedolizumab Intravenous as a therapy in pediatric patients with moderately to severely active Ulcerative Colitis
Sponsor: Takeda
Phase of Trial: Phase IIB
Start date: October 2020
Completion date: January 2025
Participation: See all inclusion and exclusion criteria here
- The subject is aged 2 to 17 years, inclusive, at the time of screening and enrollment into the maintenance phase of the study.
- The subject weighs ≥10 kg at the time of screening and enrollment into the study.
- Subjects with UC diagnosed at least 1 month before screening. Subjects with moderately to severely active UC based on a modified Mayo score of 5 to 9 (sum of Mayo endoscopic subscore, stool frequency subscore, and rectal bleeding subscore) with a Mayo endoscopic subscore of ≥2 (with the presence of mucosal friability excluding an endoscopic subscore of 1 and mandating a score of at least 2) at screening endoscopy.
- Subjects who have failed, lost response to, or been intolerant to treatment with at least 1 of the following agents: corticosteroids, immunomodulators (eg, azathioprine, 6-mercaptopurine, methotrexate), and/or TNF α antagonist therapy (eg, infliximab, adalimumab). This includes subjects who are dependent on corticosteroids to control symptoms and who are experiencing worsening of disease when attempting to wean off corticosteroids.
- Subjects with evidence of UC extending proximal to the rectum (ie, not limited to proctitis), at a minimum.
- Subjects with extensive colitis or pancolitis of >8 years’ duration or left-sided colitis of >12 years’ duration must have documented evidence of a negative surveillance colonoscopy within 12 months before screening.
- Subjects with vaccinations that are up-to-date based on the countrywide, accepted schedule of childhood vaccines.
Contact:
Purpose of study: To study the use of Vedolizumab Intravenous as a therapy in pediatric patients with moderately to severely active Crohn’s Disease
Sponsor: Takeda
Phase of Trial: Phase IIB
Start date: October 2020
Completion date: March 2025
Participation: See all inclusion and exclusion criteria here
- Subjects male or female aged 2 to 17 years, inclusive, who weigh ≥10 kg at the time of screening and enrollment into the study.
- Subjects with CD diagnosed at least 1 month before screening. Subjects with moderately to severely active CD defined by a PCDAI >30 and an SES-CD >6 (or an SES-CD ≥4 if disease is confined to terminal ileum) at screening endoscopy.
- Subjects who have failed, lost response to, or been intolerant to treatment with at least 1 of the following agents: corticosteroids, immunomodulators (eg, AZA, 6-mercaptopurine, methotrexate), and/or TNF-α antagonist therapy (eg, infliximab, adalimumab). This includes subjects who are dependent on corticosteroids or exclusive or partial enteral nutrition to control symptoms and who are experiencing worsening of disease in the moderate-to-severe range when attempting to wean off corticosteroids or discontinue exclusive enteral nutrition.
- Subjects with extensive colitis or pancolitis of >8 years’ duration or left-sided colitis of >12 years’ duration must have documented evidence of a negative surveillance colonoscopy within 12 months before screening.
- Subjects with vaccinations that are up-to-date based on the countrywide accepted schedule of childhood vaccines.
Contact:
Interstitial Cystitis
Purpose of Trial: This study aims to assess whether IW-3300 is safe and works for the treatment of interstitial cystitis/bladder pain syndrome (IC/BPS). The main question the study aims to answer is whether IW-3300 helps bladder pain and other symptoms (for example, bladder burning, pressure, and discomfort). Subjects will be assigned to receive either the study drug or placebo by chance.
Treatment or Intervention: IW-3300 rectal foam
Phase of Trial: Phase 2
Sponsor: Ironwood Pharmaceuticals, Inc.
Study Start Date: 2023-03-28
Study Completion Date: 2025-10
Participation:
- 18 Years to 70 Years (Adult, Older Adult)
- Diagnosed with IC/BPS by a urologist or other clinician specializing in IC/BPS
- Chronic bladder pain associated with filling the bladder over the past 6 months
- Compliant with eDiary completion and meets weekly average daily score for bladder pain at its worst during the pretreatment period
- Has at least 1 of the following urinary symptoms over the past 6 months: nocturia ≥2 voids/night, daytime frequency >8×day, urgency
- Body mass index (BMI) ≤40 kg/m2
- Willing to use a rectally administered product once daily for 12 weeks
Contact for Study: Study Manager 617-621-7722, info@ironwoodpharma.com
Fistulas
**No Clinical Trials at this time**
Fecal Incontinence
Added April 2024
The impact of anal sphincter resistance exerciser on the strength of anal sphincter in elderly women and fecal incontinence
Purpose of Research Study: The study’s purpose is to identify how a novel apparatus, an anal sphincter resistance exerciser, combined with Kegel exercises affect anal sphincter pressure as measured by high resolution anorectal manometry.
Condition or Disease State: We are mainly working with adult fecal incontinent patients
Treatment or Intervention: 6 weeks of Kegel exercises alone or 6 weeks of Kegel exercises combined with use of an anal sphincter resistance exerciser
Type of Study (e.g., Interventional, Observational): Interventional
Participation:
Inclusion Criteria:
- Thirty healthy elderly female older than 70 years old
- Thirty fecal incontinence patients age older than 18 years old
Exclusion Criteria:
- Subjects with cervical spine disorders.
- Subjects with neurological disorders like dementia, cerebrovascular diseases.
- Subjects suffering from muscle diseases like muscular dystrophies, myopathies
- Subjects with neuro-muscular junction disorders myasthenia gravis, Eaton-Lambert disorders.
- Subjects who are pregnant or lactating.
- Subjects who have organ prolapse beyond hymen
- Subjects who are immobile Subjects who have pain that preclude them from exercise
- Subjects who have advanced medical disorders (e.g.: COPD, congestive heart failure, cirrhosis, cancer, chronic renal failure, etc.).
- Subjects who are medically unstable.
- Subjects with hip dysplasia
Study Completion Date: Study is ongoing and continuously recruiting participants.
Contact for Study: Dr. Ling Mei, Associate Professor of Medicine at the Medical College of Wisconsin, lmei@mcw.edu
Added April 2019
Purpose of study: The purpose of this study is to investigate the short term (8 weeks) and long term (1 year) efficacy and safety of translumbosacral neuromodulation therapy for fecal incontinence. Treatment is anorectal manometry, translumbosacral anorectal magnetic stimulation, anal ultrasound, and cortical evoked potentials .
Sponsor: National Institutes of Health (NIH) R01
Participation: Recurrent episodes of FI for 6 months; No mucosal disease (colonoscopy + biopsy); On a 2-week stool diary patients reported at least one episode of solid or liquid FI/week.
Contact: Yun Yan (email: YYan@augusta.edu)
Gulf War Multisymptom Illness
Purpose of study: The National Institutes of Health (NIH) and the U.S. Department of Veterans Affairs (VA) are working on a pioneering collaborative research project, the VA-NIH Investigative Deep Phenotyping (IN-DEPTH) of Gulf War Veterans Health.
The project involves two separate research studies –VA IN-DEPTH and NIH IN-DEPTH, which work together for the common goal of learning more about GWI.
The VA IN-DEPTH study identifies Gulf War Veterans with GWI and healthy veterans that served in the war.
The goal of the VA IN-DEPTH study is to identify participants for eligibility in the NIH study. Interested veterans can volunteer to participate in Project IN-DEPTH by contacting the VA-IN DEPTH study team, who are actively recruiting participants nationwide. After an initial phone screening process and study consent is completed, the eligibility screening is performed. It includes medical tests, questionnaires, and interviews to better understand a veteran’s health and service during the Gulf War. This will be done primarily via phone and video calls.
The NIH IN-DEPTH study is focused on making scientific measurements of the Gulf War veterans identified during VA IN-DEPTH. The goal of the NIH IN-DEPTH research study is to thoroughly describe the clinical and biological characteristics of GWI. Participants in the study will not receive treatment. However, insights from this study may lead to:
- More definitive diagnostic criteria
- Development of new diagnostic testing
- Identify potential treatments
Sponsors:
- National Institutes of Health
- U.S Department of Veteran Affairs
Participation: All participants must be
- 48-70 years old
- have at least a 7th grade education.
- In addition, all eligible participants must fit into one of the two groups below:
- Gulf War illness group: Those with GWI that started after deployment to the Gulf War between 1990-91
- Healthy Veteran Control group: Those with GWI symptoms that started after deployment to the Gulf War between 1990-91.
Contact:
- VA IN-DEPTH Team: vhawas.indepth@va.gov
- NIH IN-DEPTH Team: gwiindepth@ninds.nih.gov
Learn more about these studies here
Purpose of research: The onset of certain gastrointestinal (GI) disorders, including irritable bowel syndrome (IBS), functional dyspepsia, and chronic abdominal pain syndrome, can be triggered by severe stress and infections of the digestive tract. Deployed military personnel face an elevated chance of experiencing these risk factors and developing a disorder as a result of their service. A prominent condition affecting Veterans of the Gulf War theater of operations is a cluster of medically unexplained chronic symptoms. Collectively, these are referred to as “multisymptom illness.”
The War Related Illness and Injury Study Center (WRIISC) regularly conducts research into these illnesses to understand the underlying mechanisms and develop treatments to help manage symptoms.
Sponsor: US Department of Veterans Affairs (VA)
Participation: Veterans of active service in the Gulf War theater of operations.
Contact: For more information or to participate go to www.warrelatedillness.va.gov.
Gut Microbiome
Added September 2023
Purpose of trial: Trillions of tiny organisms-including bacteria, fungi, and viruses-live inside our intestines. These microorganisms break down nutrients in our food, aid our immunity, and help keep us healthy. The population balances among these organisms can vary in different people due to factors including genetics, lifestyle, and diet. More studies are needed to understand how dietary habits affect our intestinal microorganisms.
Sponsor: National Institutes of Health Clinical Center (CC)
Start date: 2022-08-26
Completion date: 2027-04-01 (estimated)
Participation:
- Ability of subject to understand and the willingness to sign a written informed consent document
- All genders, races, and ethnicities
- Age 18-60, at the time of consent
- Willingness to adhere to the dietary regimen and report any major stressors that occur during the study (i.e. changing jobs, moving, death of a close relative/friend, etc.)
- Willingness to provide blood and stool specimens as specified
- BMI >=18 and <= 35 kg/m^2
- Access to necessary resources for participating in a technology-based intervention: computer, smartphone, internet access, etc.
- Has the ability/transportation methods to attend on-site visits
- For 50 of the 60 participants in short-term cohort and for 40 of the 50 participants in the long-term cohort: Currently following a Western diet with PREDIMED-17 MedDiet score <= 7 for >= 1 months and a CLEAN-MED NOVA score of >= 35% kcal in NOVA 4 category with >= 14 items/week in NOVA 4
- For 10 of the 60 participants in short-term cohort and for 10 of the 50 participants in the long-term cohort: Currently following a Western diet with PREDIMED-17 MedDiet score <= 10 for >= 1 months and a CLEAN-MED NOVA score of >= 20% kcal in NOVA 4 category with >= 7 items/week in NOVA 4
- CLEAN-MED Logging Score of >= 43 after initial trial week to continue in the study for the randomization step
- For long-term cohort only: Have resources and capability to consume freshly-cooked (i.e. not pre-packaged or frozen) meals
Contact: Stephanie R Burrison, R.N., (202) 941-8728 Email: cleanmed@cc.nih.gov
Colorectal Cancer
Added February 2024
Purpose of study: Researchers are trying to determine whether certain microbiome cause cancer or whether they are part of the microbiome in the gut due to the presence of cancer.
Sponsor: Mayo Clinic
Collaborators:
- National Institutes of Health (NIH)
- National Cancer Institute (NCI)
Start date: June 2021
Completion date: June 2026
Participation:
- 18 years of age or older
- Patients undergoing bowel resection by any standard surgical approach.
Contact for study:
-
Jennifer A Martin, (507) 266-6404, martin.jennifer2@mayo.edu
Added December 2023
Purpose of the study: The MyBestGI study evaluates three different approaches that could help people eat in healthier ways. The study seeks to enroll 240 overweight and obese persons who have risk factors for colorectal cancers such as a family or personal history of colorectal cancers or adenomatous polyps.
Sponsor: University of Michigan
Collaborators:
- National Cancer Institute (NCI)
Start date: April 2023
Completion date: July 2027
Participation:
- Men and women ages 19 and older
- The participant has been properly informed of the study, they agree to participate, and sign the Informed Consent document
- Body mass index of 25-45 kg/m2 or waist circumference > 88 cm for women or > 102 cm for men
- Stable weight, within five pounds, in the last two months as determined by self-report
-
Increased risk of colorectal cancer as defined by one or more of the following:
- Prior adenomatous polyp
- Prior resected early-stage CRC (Stage I-IIIA or T1-3, N0-1, M0)
- History of CRC in at least one primary relative or in at least two secondary relatives
- A known genetic condition that increases risk of CRC
- Good general health
- Have reasonable control over their own dietary intakes
- Not expecting major lifestyle changes in the next 12 months.
- Have and willing to use a compatible smartphone with a cellular data for the study.
- Can be contacted by telephone for study support calls
- Read, write, and speak English
- Are able to follow a diet high in fiber-containing foods
- Agree to be randomized to a control condition of usual care versus a dietary intervention involving app use and telephone contacts
- Successfully complete three 24-hour dietary recalls before visit 2 with plausible dietary intakes
- If taking medications for conditions that are affected by diet (diabetes, high blood pressure), must be willing to continue to follow-up with their personal medical provider as needed to manage those conditions and the medication dosing, which may need to be adjusted due to diet changes.
Contact: Rob Adwere-Boamah, 734-232-4971, MyBestGIstudy@umich.edu
Purpose of the study: The main aim of the study is to check gene change in tumor tissues with an additional analysis of the data from PARADIGM Exploratory Study, which is conducted for people with advanced/recurrent colorectal cancer.
In the PARADIGM Exploratory Study (NCT02394834), the drug being tested in this study is called Panitumumab and the main aim of this study is to check side effect from the study treatment (mFOLFOX6 + bevacizumab versus mFOLFOX6 + panitumumab therapy) and check if the study treatment improves symptoms of advanced/recurrent colorectal cancer.
Sponsors: Takeda
Start Date: August 31, 2021
Completion Date: July 31, 2024
Participation:
- 29-79 years old
- All sexes
- Not accepting Healthy volunteers
- Participants enrolled in the PARADIGM Exploratory Study (NCT02394834) who have consented to the secondary use of samples and genomic data and have not withdrawn their consent.
- Participants enrolled in the PARADIGM Exploratory Study (NCT02394834) who have consented to the secondary use of samples and genomic data and have not withdrawn their consent. Participants with sufficient surplus samples for gene expression/mutation and pathomorphologic (IHC, IF and/or ISH, etc.) analysis.
Contact: Takeda Contact +1-877-825-3327 medinfoUS@takeda.com
Functional Constipation/Chronic Idiopathic Constipation
Added June 2024
Purpose of Trial: There are no current, approved therapies to treat children 2 to 5 years of age with functional constipation (FC). Therefore, this study is designed to assess the safety and efficacy of an investigational drug in pediatric patients ages 2 to 5 years of age with functional constipation.
Sponsor: AbbVie
Study Start Date: December 22, 2022
Study Completion Date: November 14, 2025
Condition or Disease State: Pediatric Functional Constipation
Participation:
a. Are between 2 and 5 years and 11 months old.
b. Have a history of painful or hard bowel movements.
c. Meet additional study criteria.
Contact for Study:
If you are interested in this study for your child, please talk to your doctor and complete the online screener to see if your child qualifies for this study: https://pediatric-constipation-study.com/PAG/
To learn more about this study, please visit: https://www.clinicaltrials.gov/study/NCT05652205
Added January 2022
Purpose of Study: Prucalopride is a medicine used to treat constipation. The main aim of the study is to measure prucalopride concentrations in breast milk. Other aims are to check the growth and development of babies breastfed by their mothers who took prucalopride and to check if the babies had any side effects.
During the study, participants will provide one set of milk samples over 24 hours using an electric breast pump. Breast milk samples will be collected at home and will be shipped to the laboratory.
Also, participants will be asked questions during telephone interviews every 2 months in the first year of their baby’s life. They will also be asked to complete growth and development questionnaires about their baby.
Sponsors: Takeda
Start Date: December 31, 2021
Completion Date: May 30, 2025
Participation: See study for all inclusion and exclusion criteria
- 18 years or older
- Females only
Contact: Takeda Contact +1-877-825-3327 medinfoUS@takeda.com
Purpose of the study: Researchers are trying to better understand why constipation occurs and improve the tests for diagnosing these conditions.
Sponsors: Mayo Clinic
Start date: January 29, 2019
Completion date: December 30, 2023
Participation: View study for all inclusion and exclusion criteria
- 18-80 years old
- All sexes
- Accepts healthy volunteers
- Inclusion Criteria
- Male and female volunteers aged 18-80 years.
- Able to provide written informed consent before participating in the study.
- Able to communicate adequately with the investigator and to comply with the requirements for the entire study.
- Individuals with chronic constipation for 1 year, with 2 or more of the following symptoms for 3 months or longer: <3 bowel motions/week, straining ≥ 25% of time, hard or lumpy stools ≥ 25% of time, anal digitation ≥ 25% of time, incomplete evacuation ≥ 25% of time, feeling of anorectal blockage ≥ 25% of time.
- Able to provide written informed consent before participating in the study.
- Able to communicate adequately with the investigator and to comply with the requirements for the entire study.
Contact:
- Kelly J Feuerhak 507-255-6802 or via email at Feuerhak.Kelly@mayo.edu
Esophageal Cancer
Added June 2021
Esophageal Cancer Risk Registry
Purpose of study: The purpose of this study is to identify markers in the blood and tissue that could indicate risk factors for the development and progression of esophagus cancer. This research aims to collect medical history, blood, and tissue samples from patients who present with an esophageal disorder. Identifying genetic and behavioral risk factors involved in the development of esophageal cancer might allow for early detection and prevention. Survival and an opportunity for a cure with esophageal cancer will depend greatly on the stage of diagnosis. Tumors can develop changes in their genetic (hereditary) make-up, and these changes can sometimes be seen in normal tissues before the development of cancer. These genetic (hereditary) changes can serve as tumor markers and can be detected using methods that study changes in genetic material like DNA and RNA. The analysis of proteins can provide additional information. By identifying changes in these molecules that are different or altered in cancer, the investigators can use methods and tests for the detection of these changes.
Sponsor: University of Pittsburgh
Collaborators: National Institutes of Health (NIH) and National Cancer Institute (NCI)
Participation: (Visit the website for more details on specific inclusion and exclusion criteria)
- Known or suspected esophageal or gastroesophageal junction malignancy
- Known Barrett’s metaplasia
- Clinical management of symptomatic gastroesophageal reflux disease (GERD)
- Achalasia
- Hiatal hernia
Start date: June 1999
Completion date: December 2050
Contact:
- Julie A Ward, BSN 412-647-8583 or email at wardj@upmc.edu
- Judy Forster, BSN 412-647-8579 forsej@upmc.edu
Short Bowel Syndrome (SBS)
Functional Sucrase Deficiency in Short Bowel Syndrome Patients With Intestinal Failure
Purpose of study: In patients with short gut syndrome and intestinal failure, the administration of exogenous sucrase (enzyme) may improve sucrose (sugar) digestion and thus the ability to tolerate more oral or g-tube feeds.
Sponsor: University of Miami
Start date: February 2022
Completion date: January 2025
Participation:
- Short bowel syndrome, of all ages, with dependence on parental support to provide at least 50% of fluid or caloric needs.
- Must be on diet containing sucrose.
- Must be willing and able to sign informed consent
- Adult and Pediatric patients (all ages)
Contact for study:
- Name: Amanda Fifi, MD, 3052433166, afifi@med.miami.edu
- Name: Cara Axelrod, RD, 3052433166, cxa630@med.miami.edu
Eosinophilic Disorders
Added February 2024
Study of Gastric Motility in Eosinophilic Gastritis(OAT-FEED)
Purpose of study: The study is a cross-sectional observational study designed to determine if eosinophilic gastritis (EG) results in gastric motility impairment.
Sponsor: Children’s Hospital Medical Center, Cincinnati
Start date: January 2023
Completion date: July 2024
Participation:
Inclusion Criteria:
- 18 to 59 years old with EG
- Eosinophilic gastritis (EG) defined as at least one endoscopy with histopathologic evidence of ≥ 30 eosinophils in 5 or more high powered fields (hpf’s) with associated symptoms of EG.
- Patient reported symptoms starting at least one year or more prior to screening consistent with a diagnosis of EG: nausea, vomiting, early satiety, abdominal pain/bloating, regurgitation, diarrhea.
- Symptoms suggestive of a possible gastric motility disorder during the 60 days prior to screening including: nausea, vomiting, early satiety, post-prandial feeling of fullness or bloating.
- Tolerance and willingness to consume the oatmeal meal in this study.
Contact:
- Kara Kliewer, PhD 513-636-4821 kara.kliewer@cchmc.org
Added November 2022
Data and Sample Collection Study to Elucidate the Mechanisms of Eosinophilic Disorders
Purpose of study: The purpose of this study is to elucidate the mechanisms underlying eosinophil growth, survival, migration, and function and to investigate and further characterize the pathophysiology of, clinical manifestations of, and spectrum of disease severity of eosinophilic inflammation in humans.
Sponsor: Children’s Hospital Medical Center, Cincinnati
Start date: May 2005
Completion date: January 2050
Participation:
Patients with eosinophilic disorders and patients without eosinophilic disorders to serve as normal control
Inclusion Criteria:
- Signed informed consent obtained from the patient or parent/guardian. Assent will be obtained from all minors 11 years of age and older.
- Carrying a diagnosis of eosinophilic gastrointestinal disease, eosinophilic inflammatory disease, or food allergy OR family member, or normal control
Contact:
- Kara Kliewer, PhD 513-636-4821 kara.kliewer@cchmc.org
Added June 2022
Purpose of the study: The purpose of this observational study is to find the best measures to define how well a person with eosinophilic disorder is doing. People with EoE, EG, EGE and EC normally undergo endoscopy and/or colonoscopy where cells are collected for microscopic analysis. Treatments are then decided based on how the cells look. We are aiming to compare different tissue components such as inflammatory cell types with clinical symptoms. We want to see if scores on standard questionnaires can give us an idea how well the person is doing.
Sponsor: Children’s Hospital Medical Center
Collaborators: National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ORDR
National Center for Advancing Translational Science (NCATS)
Start Date: July 2015
Completion Date: December 2050
Participation:
Inclusion Criteria:
- Males or females 3 years of age and older
- Mucosal eosinophilia: EoE ≥ 15 eosinophils/HPF in the distal or proximal esophagus, EG ≥ 30 eosinophils/HPF in 5 HPF’s in the body and/or antrum, EGE ≥ 53 eosinophils/HPF in the duodenum and/or ≥ 56 eosinophils/HPF in the jejunum and/or ileum, EC ≥ 84 eosinophils/HPF from the transverse or descending colon and/or ≥ 32 eosinophils/HPF from the rectosigmoid colon or a biopsy from any colonic location with ≥ 100 eosinophils/HPF
- Presence of symptoms is required for patients who are newly diagnosed but not required for patients who were previously diagnosed.
Exclusion Criteria:
- History of intestinal surgery other than G tube placement
- Enrolled in a blinded investigational study at the time of the first study visit
- Have esophageal stricture (<3mm)
- Have other identifiable causes for eosinophilia (except Inflammatory Bowel Disease): infections, Gastrointestinal (GI) cancer, other GI inflammatory disease (e.g., Ulcerative Colitis or Crohn’s Disease)
Contact:
- Heidi Poppendeck, MPH 513-803-3078 heidi.poppendeck@cchmc.org
- Kara Kliewer, PhD (513) 636-4821 Kara.Kliewer@cchmc.org
Added May 2021
Purpose of research: Single center observational and specimen banking study for children with eosinophilic esophagitis EoE to gauge natural history and inflammatory markers.
Sponsor: University of California, San Diego, NIH and NIAID
Participation:
Have a known EoE diagnosis
Complain of dysphagia, vomiting, or abdominal pain, especially if recalcitrant to acid blocking therapy (but does not have to be recalcitrant to acid blocking medications)
Present with food impaction
Present with esophageal stricture
Have characteristic endoscopic findings of EoE of pallor, linear furrows, lichenification, white plaques, or concentric rings
Contact:
Contact: Emad Khosh hemmat, BS 8589661700 ext 226884 ekhoshhe@Ucsd.edu
Contact: Seema S Aceves, MD, PhD 8585342983 saceves@ucsd.edu
Erosive Esophagitis
Added July 2023
Purpose of study: The objective of the Healing Phase of the study is to evaluate the safety and efficacy of up to 8 weeks of once daily oral administration of BLI5100 versus a PPI control in healing EE. The objective of the Maintenance Phase of the study is to evaluate the safety and efficacy of 24 weeks of once daily oral administration of BLI5100 (low or high dose) versus a PPI control in the maintenance of healed EE.
Sponsor: Braintree Laboratories
Start Date: October 2022
Completion date: June 2024
Participation:
- Aged ≥18 years at the time of signing informed consent;
- Have experienced both heartburn and regurgitation within 7 days prior to the Screening Visit;
- Current evidence of EE of LA grades A to D based on an upper GI endoscopy;
- Able to understand and comply with the protocol requirements;
- Willing and able to provide written informed consent at Screening;
- Is a female of non-childbearing potential, ie, is either surgically sterile (ie, had a hysterectomy, bilateral tubal ligation, salpingectomy, and/or bilateral oophorectomy ≥6 months before the Screening Visit) or post-menopausal, defined as spontaneous amenorrhea for ≥12 months, and, for females <55 years of age, with follicle-stimulating hormone in the post-menopausal range at Screening, based on the central laboratory’s ranges; or If a female of childbearing potential, agrees to use an acceptable form of birth control from the Screening Visit until 30 days after the last dose of study drug.
- If a male, agrees to use an acceptable form of birth control from the Screening Visit until 3 months after the last dose of study drug.
- If a male, agrees to abstain from sperm donation through 3 months after administration of the last dose of study drug.
Contact: Leah Hollins, Braintree Laboratories / Sebela Pharmaceuticals, 781-843-220, studydirector@sebelapharma.com
Diverticulitis
Added September 2023
Purpose of study: This is a randomized trial (n=75) of a Mediterranean style Food Pattern and versus standardized guidance on fiber intake for patients with diverticulitis to evaluate the feasibility of this dietary intervention including willingness to randomize and adherence to a Med-style dietary pattern. The investigators will employ state-of-the-art behavioral interventions in the form of electronic feedback to improve health-related behaviors and support dietary customization based on participants’ budget, dietary preferences, and restrictions. The investigators will also examine plasma inflammatory biomarkers (interleukin-6, interleukin-10, and interleukin-1β) and fecal calprotectin at baseline, 6, and 12 months.
Sponsor: University of Washington
Collaborator: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Start date: 2023-01-01
Completion date: 2025-04-01
Participation:
- Adult ≥18 years;
- Patients presenting to gastroenterologist or surgeons after recovery from an episode of diverticulitis (within the prior 18 months), either the index episode or recurrent.
- Ability to provide written informed consent in English.
Contact: Kelsey Pullar, 206-221-8247, kpullar@uw.edu
Purpose of Study: The COSMID (Comparison of Surgery and Medicine on the Impact of Diverticulitis) trial is a pragmatic, patient-level randomized superiority trial of elective colectomy vs. best medical management for patients with quality of life (QoL) limiting diverticular disease. A parallel observational cohort will include those who are disinclined to have their treatment choice randomized, but are willing to contribute information about their outcomes. The goal of the COSMID trial is to answer the question: For patients with QoL-limiting diverticular disease, is elective colectomy more effective than best medical management? The hypothesis being tested in the COSMID trial is that patient-reported outcomes (PROs) among patients in the surgery arm will be superior to those in the best medical management arm.
Sponsor: Patient Centered Outcomes Research Institute
Participation: Adults ≥18 years; At least one episode of diverticulitis confirmed by CT scan in last 5 years and a colonoscopy to rule out or screen for other colon pathology concordant with screening guidelines; AND A. History of recurrent uncomplicated diverticulitis without current symptoms (AUD in remission) over the prior 5 years; OR B. Persistent signs, symptoms, and concerns related to diverticular disease ≥3 months after recovery from an episode of AUD (e.g., excluding irritable bowel syndrome and other conditions in coordination with gastroenterologist)
Contact: Kelsey Pullar kpullar@uw.edu
Dyspepsia
***No clinical trials at this time***
Dysphagia
Added June 2022
Purpose of the study: This multi-site trial will follow a cohort of Veterans with dysphagia for 8 weeks as they undergo clinically guided oropharyngeal exercises with oropharyngeal strengthening as the primary goal. Veterans with dysphagia will be assessed at three time points: baseline, 4 weeks after treatment initiation, and 8 weeks after treatment initiation. A non-dysphagic Veteran control group will also undergo data collection at parallel time points, without completion of a treatment paradigm. The investigators will then compare patients to non-dysphagic controls using manometry, videofluoroscopy, diet assessment, functional reserve tests, and patient-reported outcome measures.
The investigators aim to 1) quantify change in pressure measures of swallowing function resulting from dysphagia treatment; 2) determine which combination of standard of care and/or pressure-based metrics best track with outcome measures; and 3) develop multimodal prognostic algorithms that predict treatment success. This research will establish a precise outcome measurement paradigm suitable for dysphagia clinical care and research, thus improving clinical confidence and paving the way for a personalized medicine approach for dysphagia rehabilitation in Veterans
Sponsors: VA Office of Research and Development
Start date: June 2021
Completion Date: September 30, 2025
Participation:
- 18-99 years old
- All sexes
- Accepting healthy volunteers
Inclusion Criteria:
Signed an informed consent form
Receive a dysphagia diagnosis by a speech-language pathologist
Must have a dysphagia treatment plan with the goal of strengthening the oropharyngeal musculature
English speaking
Exclusion Criteria:
history of allergic response to barium
history of allergic response to topical anesthetics
Contact:
- Aaron F Heneghan, PhD (608) 256-1901 ext 17801 Aaron.Heneghan@va.gov
- Jenna W Quinto, PhD (680) 256-1901 ext 17865 jenna.quinto@va.gov
Added January 2022
Purpose of Study: This study will examine the effects of varying liquid viscosity on swallow physiology in infants with oropharyngeal dysphagia and brief resolved unexplained event (BRUE) and other children with dysphagia that would be at risk for symptoms of swallow dysfunction.
Sponsors: Boston Children’s Hospital
Collaborators: NIDDK
Start Date: April 1, 2021
Completion Date: August 31, 2025
Participation: See study for all inclusion and exclusion criteria
- 0-21 years of age
- ALL sexes
- NOT accepting healthy volunteers
Contact: Daniel R Duncan, MD, MPH 617-355-0897 daniel.duncan@childrens.harvard.edu
Cyclic Vomiting Syndrome
*** No clinical trials at this time***
Achalasia
Added January 2022
Assessment of Different Modified POEM for Achalasia
Purpose of study: The aims of this study are 1) to compare the efficacy and safety of conventional myotomy (long myotomy) and modified myotomy (short myotomy) in the treatment of type I/II achalasia patients diagnosed according to Chicago Classification; 2) to compare the efficacy and safety of conventional myotomy (circular myotomy) and modified myotomy (full-thickness myotomy) in the treatment of type I/II achalasia patients; 3) to compare the efficacy and safety of conventional myotomy (non-tailored myotomy) and modified myotomy (tailored myotomy) in the treatment of type III achalasia patients.
Sponsor: Peking Union Medical College Hospital
Start Date: September 2, 2020
Completion Date: December 2027
Participation: See study for all inclusion and exclusion criteria
- Age 14 to 70 years of age
- ALL sexes
- NOT accepting Healthy volunteers
Contact: Tao Guo, MD 8610-69155017 guoqiong990@126.com
Pancreatic Cancer
Added June 2021
Study of Pembrolizumab With or Without Defactinib Following Chemotherapy as a Neoadjuvant and Adjuvant Treatment for Resectable Pancreatic Ductal Adenocarcinoma
Purpose of Trial: This study will test the effectiveness (anti-tumor activity), safety, and ability to increase the body’s immune system to fight pancreatic cancer by combining standard chemotherapy before and after surgery, with study drug PD-1 antibody, pembrolizumab, with and without study drug, focal adhesion kinase inhibitor (FAK), defactinib, in people with “high risk” resectable (surgically removable) pancreatic cancer. The purpose of this study is to evaluate if reprograming the tumor microenvironment by targeting FAK following chemotherapy can potentiate anti-programmed death-1 (PD-1) antibody.
Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Participation:
- Age ≥18 years.
- Has pancreatic ductal adenocarcinoma
- Has resectable disease at the time of diagnosis
- Has not received any systemic therapy for pancreatic ductal adenocarcinoma
- Has stage ≤ IIb disease at time of diagnosis and enrollment
- Elevated tumor marker, CA (carbohydrate antigen) 19-9 >200
- ECOG performance status 0 or 1
- Patient must have adequate organ function defined by the study-specified laboratory tests.
- Must use acceptable form of birth control while on study.
- Ability to understand and willingness to sign a written informed consent document.
Start Date: May 28, 2019
Completion Date: May 2023
Contact:
- Susan Sartiorius-Mergenthaler, RN (410)-614-3644 or email at Sartosu@jhmi.edu
- Sheila Linden, RN (410)-614-4397 or email at slinden2@jhmi.edu
A Phase III Trial of Perioperative Versus Adjuvant Chemotherapy for Resectable Pancreatic Cancer
Purpose of Trial: This phase III trial compares perioperative chemotherapy (given before and after surgery) versus adjuvant chemotherapy (given after surgery) for the treatment of pancreatic cancer that can be removed by surgery (removable/resectable). Chemotherapy drugs, such as fluorouracil, irinotecan, leucovorin, and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving chemotherapy before and after surgery (perioperatively) may work better in treating patients with pancreatic cancer compared to giving chemotherapy after surgery (adjuvantly).
Sponsor: Alliance for Clinical Trials in Oncology
Participation: (Check website for further details on pre-registration criteria and registration criteria)
- 18 years of older (adult, older adult)
Start Date: July 2020
Completion Date: January 2026
Contact: Cristina R. Ferrone, MD (617)-643-6189, or email at cferrone@mgh.harvard.edu
Study of Pembrolizumab (MK-3475) in Participants With Advanced Solid Tumors (MK-3475-158/KEYNOTE-158)
Purpose of Trial: In this study, participants with multiple types of advanced (unresectable and/or metastatic) solid tumors who have progressed on standard of care therapy will be treated with pembrolizumab (MK-3475).
Sponsor: Merck Sharp & Dohme Corp
Participation: (See website for more details on inclusion and exclusion criteria)
- 18 years and older (adult, older adult)
Start Date: December 18, 2015
Completion date: June 18, 2026
Contact: Toll Free Number 1-888-577-8839 Trialsites@merck.com
Phase 2 Study of Olaparib Monotherapy in Participants With Previously Treated, Homologous Recombination Repair Mutation (HRRm) or Homologous Recombination Deficiency (HRD) Positive Advanced Cancer
Purpose of Trial: Precision Promise is a multi-center, seamless Phase 2/3 platform trial designed to evaluate multiple regimens in metastatic pancreatic cancer.
Sponsor: Merck Sharp & Dohme Corp. and AstraZeneca
Participation: (See website for more details on inclusion and exclusion criteria)
- 18 years and older (adult, older adult)
Start Date: December 12, 2018
Completion Date: February 13, 2024
Contact: Toll Free Number 1-888-577-8839 Trialsites@merck.com
Laryngopharyngeal reflux (LPR)
Reflux Band in Laryngopharyngeal Reflux
Purpose of study: This 12 week biomarker targeted double blind randomized controlled trial (RCT) will enroll subjects with salivary pepsin positive laryngopharyngeal reflux (LPR) to assess efficacy of the external upper esophageal sphincter (UES) compression device, also known as the Reflux Band. Subjects will be randomized to one of two arms: control or experimental. Following the 8 week intervention period subjects in both arms will continue in a 4 week unblinded period. The primary hypothesis is that a significantly higher proportion of subjects in the experimental arm will meet the primary endpoint for symptom response, compared to subjects in the control arm.
Sponsor: University of California, San Diego
Study date: 2021-05-07
Completion date: 2026-04
Participation:
- Adults between 18-99, English or Spanish speaking
- ≥8 weeks of laryngeal symptoms (dysphonia, throat clearing, cough, globus, and/or sore throat)
- Current use of double dose PPI* (equivalent to: omeprazole 40mg daily, lansoprazole 30mg daily, esomeprazole 40mg daily, dexlansoprazole 60mg daily, rabeprazole 20mg daily, or pantoprazole 80mg daily)
- Laryngoscopic exam within 12 months prior to screening with reflux finding score >7
-
At least 1 of the following:
- Elevated reflux testing
- Findings on upper endoscopy that are consistent with pathologic GERD
- Fasting pepsin analysis result of ≥25 ng/mL within 4 months of enrollment (12 months if treatment plan has not changed) *testing allowed at enrollment if not previously obtained
Contact: Esophageal Research Coordinator, 8582465236, Email: mgreytak@ucsd.edu
Liver Disease
Added January 2023
Purpose of trial: Treatment- The main aim of this study is to learn if fazirsiran reduces liver scarring (fibrosis) compared to placebo. Other aims are to learn if fazirsiran slows down the disease worsening in the liver, to get information on how fazirsiran affects the body (called pharmacodynamics), to learn if fazirsiran reduces other liver injury (inflammation) and the abnormal Z-AAT protein in the liver, to get information on how the body processes fazirsiran (called pharmacokinetics), to test how well fazirsiran works compared with a placebo in improving measures of liver scarring including imaging and liver biomarkers (substances in the blood that the body normally makes and help show if liver function is improving, staying the same, or getting worse) as well as to check for side effects in participants treated with fazirsiran compared with those who received placebo.
Sponsor: Takeda
Condition: Alpha1-Antitrypsin Deficiency
Start date: January 24, 2023
Completion date: February 28, 2028
Participation:
- The participant must have a diagnosis of the Z allele homozygotes (PiZZ) genotype AATD. PiZZ diagnosis from source verifiable medical records is permitted. Otherwise, participants must undergo PiZZ confirmatory testing (genotyping for PiS and PiZ alleles) at screening. PiMZ or PiSZ genotypes are not permitted.
- The participant, of any sex, is aged 18 to 75 years, inclusive.
- The participant’s liver biopsy core sample collected should meet the requirements of the protocol.
- The participant has evidence of METAVIR stage F2, F3, or F4 liver fibrosis, evaluated by a centrally read baseline liver biopsy during the screening period; or confirmed as meeting all the entry criteria by central reading of a previous biopsy conducted within 6 months before the estimated enrollment date using an adequate liver biopsy and slides as defined in the histopathology manual. The histopathology manual must be followed for all liver biopsies as study standard operating procedure.
- The participant has a pulmonary status meeting the protocol’s requirements.
- It must be confirmed that the participant does not have HCC. Participants will be screened for HCC with alpha-fetoprotein (AFP) and abdominal ultrasound. If the participant has any of the following, they will be required to have contrast-enhanced CT or MRI imaging to exclude HCC before randomization.
- An adult participant must have a body mass index (BMI) between 18.0 and 39.0 kilograms per meter square (kg^m2), inclusive.
- The participant is a nonsmoker (defined as does not smoke cigarettes daily for at least 12 months before screening) with current nonsmoking status confirmed by urine cotinine at screening.
Contact: 1-877-825-3327 https://www.theredwoodliverstudy.com/
Porphyria
Added March 2022
Longitudinal Study of the Porphyrias
Purpose of the study: The objective of this protocol is to conduct a longitudinal multidisciplinary investigation of the human porphyrias including the natural history, morbidity, pregnancy outcomes, and mortality in people with these disorders.
Sponsor: Icahn School of Medicine at Mount Sinai
Start Date: November 1, 2010
Completion Date: September 2024
Participation:
-
- Child, Adult, Older Adult
-
- Sexes Eligible for Study: All
-
- Accepts Healthy Volunteers: No
-
- Sampling Method: Non-Probability Sample
Study Population: Subjects will be recruited from the following resources:
-
- Patients followed by one of the Investigators
-
- The American Porphyria Foundation (APF)
-
- Non-study Physician referrals
-
- Self-referrals, including family members of individuals diagnosed with Porphyria (proband) and other individuals who may have heard about the study from other subjects or prospective subjects.
-
- Medical Records Review
Inclusion Criteria:
-
- Individuals with a documented diagnosis of a porphyria.
-
- For each type of porphyria, the inclusion criteria are based on
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- Biochemical findings, as documented by laboratory reports (or copies) of porphyria-specific testing performed after 1980 (Absolute values are preferred for diagnostic biochemical thresholds. Fold increases in comparison to an upper (or lower) limit of normal (ULN or LLN) are also acceptable, but are complicated by considerable variation between laboratories in normal limits. Equivocal biochemical measurements may require confirmation by a consortium reference laboratory;)
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- molecular findings documenting the identification of a mutation in a porphyria-related gene.
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- For each type of porphyria, the inclusion criteria are based on
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- In addition, an individual or a parent or guardian must be willing to give written informed consent or assent, as appropriate.
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- Provision is made for enrolling relatives who may not have symptoms but have biochemical or molecular documentation of a porphyria, or in the case of recessive disorders carry a disease-related mutation.
Exclusion Criteria:
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- Cases with elevations of porphyrins in urine, plasma or erythrocytes due to other diseases (i.e. secondary porphyrinuria or porphyrinemia), such as liver and bone marrow diseases;
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- Patients with a prior diagnosis of porphyria that cannot be documented by review of existing medical records or repeat biochemical or DNA testing.
Contact: Karli Hedstrom, MPH 212-659-1450 karli.hedstrom@mssm.edu
NCT01561157
Purpose of the Study: This global patient registry is being conducted to characterize the natural history and real-world clinical management of patients with AHP, and to further characterize the real-world safety and effectiveness of givosiran and other approved AHP therapies.
Sponsors: Alnylam Pharmaceuticals
Start date: April 26, 2021
Completion date: April 2027
Participation:
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- 12 years or Older
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- All sexes
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- Documented diagnosis of AHP, per physician’s determination
Contact:
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- Alnylam Clinical Trial Information Line 1-877-ALNYLAM or via email clinicaltrials@alnylam.com
H. Pylori
** No active clinical trials
