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.

All GI Disorders

 

Added May 2023

GI Permeability Change in Response to Aquamin®

Added April 2023

Development and validation of a self-report general mental health scale for patients with functional gastroduodenal disorders

Purpose of study: This study aims to examine the psychometric properties and validate a newly developed general mental health screening scale, developed for use in patients with functional gastroduodenal disorders. Type of Study: A 15-20 minute anonymous, online survey

Condition: Functional gastroduodenal disorders (e.g. Gastroparesis, Functional dyspepsia, Chronic nausea and vomiting syndrome, Cyclic vomiting syndrome, Rumination syndrome, Cannabinoid hyperemesis syndrome, or a belching disorder)

Sponsor: The University of Auckland

Study Start Date: 17 April 2023

Study Completion Date: Unknown

Participation: To take part you must be 18 years or older and be able to speak, read, and write fluently in English. You must also meet the diagnostic criteria for a functional gastroduodenal disorder, such as;
• Gastroparesis
• Functional dyspepsia
• Chronic nausea and vomiting syndrome
• Cyclic vomiting syndrome
• Rumination syndrome
• Cannabinoid hyperemesis syndrome
• A belching disorder

People from any country can participate. You cannot take part in this study if you vomit because you make yourself vomit (self-induced vomiting) or have an eating disorder. If you are in prison or long-term care, or if you have cognitive impairment, you cannot take part in this study. If you are unsure if you meet these criteria, you can complete the screening questionnaire at the start of the survey, which will assess your eligibility.

Contact for Study: Dr. Mikaela Law, m.law@auckland.ac.nz

Link to survey

Clinical Trial Identifier # Registered at ANZCTR.org.au (ACTRN12623000385640)

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

Survey Link

Added November 2022

Purpose of Trial: This study is a multi-center, randomized, double-blind, placebo-controlled study in participants 1 to less than 56 years of age who are allergic to peanut and at least two other foods (including milk, egg, wheat, cashew, hazelnut, or walnut). While each participant may be allergic to more than two other foods, the primary endpoint/outcome in this study will only be assessed in peanut and two other foods for each participant. The primary objective of the study is to compare the ability to consume foods without dose-limiting symptoms during a double-blind placebo-controlled food challenge (DBPCFC), after treatment with either omalizumab or placebo for omalizumab.

Condition: FGIDs

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Collaborators: 

• Genentech, Inc.
• Novartis Pharmaceuticals
• Rho Federal Systems Division, Inc

Start Date: July 22, 2019

Completion Date: November 2023

Participation: See all inclusion and exclusion criteria

• 1-55 years old
• Male or female
• NOT accepting healthy volunteers

NCT03881696

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

  Exclusion Criteria:

  • Patients with the following cardiac diagnoses: ventricular tachycardia or fibrillation; Torsades de pointes; clinically significant bradycardia; sinus node dysfunction; heart block; prolonged corrected QT (QTc) interval (QTc > 450 milliseconds for males, QTc > 470 milliseconds for females); valvular, ischemic, or pulmonary heart disease; cardiomyopathy; history of heart failure
  • Patients who are receiving antiarrhythmic medications with action on repolarization times (with prolongation of the QTc interval such as amiodarone, disopyramide, dofetilide, flecainide, ibutilide, quinidine, sotalol, dronedarone etc.)
  • Patients who are receiving monoamine oxidase (MAO) inhibitors
  • Patients with a history of or active liver failure
  • Clinically significant electrolyte disorders including sodium < 130 or > 145 and/or potassium < 3.0 or > 5.5 and/or magnesium < 1.6 or > 2.6
  • GI hemorrhage or obstruction experienced within the previous 6 weeks
  • Presence of a prolactinoma (prolactin-releasing pituitary tumor)
  • Pregnant or breast-feeding female (women of childbearing potential [WOCBP], defined as not post-menopausal for 12 months or without previous surgical sterilization, must have a negative urine pregnancy test within 30 days of the first administration of domperidone and must either commit to continued abstinence from heterosexual intercourse or use an effective method of birth control during the course of the study)
  • Known allergy to domperidone

Contact: Mehnaz Shafi 713-794-5073 mashafi@mdanderson.orgs

NCT01696734

Added October 2022

Patient and Clinician User Needs for Psychometric Questionnaires in Body Surface Gastric Mapping- Interview Study Protocol

Purpose of Trial: To investigate the opinions of patients and clinicians on the use of psychological information in the diagnosis and management of patients with functional gastrointestinal disorders (FGIDs). This study involves a 30-60 minute online semi-structured interview exploring your views and opinions.

Condition: Functional Dyspepsia, chronic nausea, gastroparesis

Sponsor: The University of Auckland

Start Date: July 2022

Completion Date: January 2023

Participation:

• 18 years or older and be able to speak, read, and write fluently in English. You must also meet the following diagnostic criteria for functional dyspepsia, chronic nausea and vomiting syndrome, or gastroparesis.
• Functional Dyspepsia: You must have at least one of the following symptoms over the past three months, with the onset of symptoms at least six months prior:
  • Bothersome postprandial fullness: feeling uncomfortably full after regular sized meal, more than one day a week
  • Bothersome early satiation: being unable to finish a regular sized meal, more than one day a week
  • Bothersome epigastric pain or burning: having pain or burning in middle of abdomen, at least one day a week
• Chronic Nausea and Vomiting Syndrome: You must have bothersome conausea at least one day per week and/or one vomiting episode per week over the past three months, with the onset of symptoms at least six months prior
• Gastroparesis: You must have a diagnosis of gastroparesis as confirmed by a standardized gastric emptying scintigraphy study.

You cannot take part in this study if you vomit because you make yourself vomit (self-induced vomiting) or have an eating disorder.

Contact: Dr. Mikaela Law: m.law@auckland.ac.nz

Link to survey: For more information and to register your interest, please complete the following 5-minute survey. https://auckland.au1.qualtrics.com/jfe/form/SV_3g7xGkXg17E20Cy

Added May 2022

Added February 2022

Purpose of study: Brand-X Usability Study is a research study to investigate whether people with certain GI conditions can use the pen injector in development safely and effectively

Start date: May 2022

Completion Date: July 2022

Participation:

• 18 years or older
• All Sexes
• NOT accepting healthy volunteers

Inclusion Criteria:

Adult patients with Short Bowel Syndrome (SBS, also known as Short Gut or Short Gut Syndrome) or other GI conditions such as Crohn’s disease, Ulcerative Colitis, Chronic pancreatitis, Chronic idiopathic intestinal pseudo obstruction, High-output fistula,  with or without subcutaneous injection experience.

Non-professional caregivers (in home setting, generally a family member) of adult patients with Short Bowel Syndrome (SBS, also known as Short Gut or Short Gut Syndrome) or other GI conditions such as Crohn’s disease, Ulcerative Colitis, Chronic pancreatitis, Chronic idiopathic intestinal pseudo obstruction, High-output fistula with or without subcutaneous injection experience.

Exclusion Criteria: NA (the recruiter will conduct the screening process)

Contact: 

• Recruiter: Medivoice Recruit: brand-x.recruitment@medivoicerecruit.com

If you are interested in participating, please follow the attached link, answer the questions and hit submit. The recruiting firm, Medivoice Recruit, will then reach out if you qualify.

https://wh1.snapsurveys.com/s.asp?k=161952292353

Added January 2022

 

Purpose of study: To evaluate the effects of tradipitant relative to placebo on satiation, gastric volume, gastric accommodation, and gastric emptying in healthy volunteers.

Sponsor: Vanda Pharmaceuticals

Start date: February 1, 2021

Completion Date: October 2021

Participation: See study for all inclusion and exclusion criteria

• 18 years to 65 years old
• All sexes
• Accepts healthy volunteers

Contact: 

• Vanda Pharmaceuticals 202-734-3400 clinicaltrials@vandapharma.com

NCT04849559

 

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

NCT02504853

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

NCT01034670

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 January 2020}

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: National Institute of Allergy and Infectious Diseases (NIAID)

Participation: Individuals who meet all of the following criteria are eligible for enrollment as study participants:

Participant and/or parent/legal guardian must be able to understand and provide informed consent and/or assent, as applicable;
Peanut allergic: participant must meet all of the following criteria to minimize the chance that the participant will develop natural tolerance to peanut over the course of the study:

Positive skin prick test (SPT) defined as ≥4 mm wheal greater than saline control) to peanut, Positive peanut immunoglobulin E (IgE), ≥6 kUA/L, at Screening or within three months of Screening, determined by ImmunoCap, and Positive double-blind placebo-controlled food challenge (DBPCFC), defined as experiencing dose-limiting symptoms at a single dose of ≤100 mg of peanut protein. Allergic to at least two of the six other foods (milk, egg, wheat, cashew, hazelnut, walnut): each participant must meet all of the following criteria for at least two of the six other foods to minimize the chance that the participant will develop natural tolerance to at least two of the six other foods over the course of the study:

Positive SPT (≥4 mm wheal) to food,
Positive food specific IgE (≥6 kUA/L) at Screening or within three months of Screening, determined by ImmunoCap, and
Positive DBPCFC, defined as experiencing dose-limiting symptoms at a single dose of ≤300 mg of food protein.
With body weight (as measured at Screening) and total serum IgE level (as measured within three months of Screening) suitable for omalizumab dosing;
If female of child-bearing potential, must have a negative urine or serum pregnancy test;
For women of childbearing potential, must agree to: remain abstinent (refrain from heterosexual intercourse), use acceptable contraceptive methods (barrier methods, oral, injected, or implanted hormonal methods of contraception, or other forms of hormonal contraception that have comparable efficacy), during the treatment period and for 60 days after the last dose of study drug.

Plan to remain in the study area of a Consortium for Food Allergy Research (CoFAR) clinical research unit (CRU) during the trial; and
Be willing to be trained on the proper use of the Epinephrine Autoinjector.

About the study: This study is a multi-center, randomized, double-blind, placebo-controlled study in participants 2 to less than 56 years of age who are allergic to peanut and at least two other foods (including milk, egg, wheat, cashew, hazelnut, or walnut). While each participant may be allergic to more than two other foods, the primary endpoint/outcome in this study will only be assessed in peanut and two other foods for each participant. The primary objective of the study is to compare the ability to consume foods without dose-limiting symptoms during a double-blind placebo-controlled food challenge (DBPCFC), after treatment with either omalizumab or placebo for omalizumab.

Contact: For more information, visit https://www.nih.gov/ or https://clinicaltrials.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

_{Added April 2020}

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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

NCT04561518

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Covid-19

Added January 2022

Purpose of the study: This study is an adaptive, randomized, open-label, controlled clinical trial, in collaboration with countries around the world through the World Health Organization. Subjects will be randomized to receive either standard-of-care products or the study medication plus supportive care, while being hospitalized for COVID-19.

Participants will be randomized to one of the following groups:

1. Remdesivir 200mg IV on day 1, followed by 100 mg IV daily infusion for 9 days plus optimized supportive care, OR
2. Interferon-beta-1a, 22 or 44 micrograms subcutaneously on days 1, 3 and 6, plus optimized supportive care OR
3. Optimized support care, all or until discharge from hospital, whichever occurs first

Sponsor: Sunnybrook Health Sciences Centre

Collaborators: AbbVie and Apotex Inc.

Start Date: March 18, 2021

Completion Date: May 18, 2022

Participation: See study for all inclusion and exclusion criteria

• 18 years and older
• Male and female
• NOT Accepting healthy volunteers

Contact:

• Srinivas Murthy, MD (604) 875-2778 srinivas.murthy@cw.bc.ca
• Gail Klein 416-480-5632 CATCO@sunnybrook.ca

NCT04330690 

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Coexisting Conditions

Added November 2022

Intestinal Inflammation in CF Patients

Purpose of Trial: Cystic Fibrosis (CF) is a disease that affects salt and water transport in multiple organs. Many CF patients suffer from abdominal pain and this could be due to intestinal inflammation. However, so far we do not know how many of the CF patients actually do have intestinal inflammation when looking at intestinal specimens. There is a proven connection between chronic inflammation and developing colorectal cancer and over the years more CF patients are developing colorectal cancer. Thus, it becomes increasingly important to look for the presence of intestinal inflammation in CF patients since early treatment may improve their symptoms and reduce the risk for colorectal cancer.

 

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

NCT04221230

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 Barrett’s Esophagus

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

NCT02994693  

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: For more information, please visit: clinicaltrials.gov/

Contact: Anna Gao, RN 617-643-6092 Tearneylabtrials@partners.org
Contact: Anita Chung, RN 617-724-4515 Tearneylabtrials@partners.org

_{Added February 2020}

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C. Difficile Infection (CDI)

 

**Currently no active trials**

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Gastroesophageal Reflux Disease (GERD)

Added June 2021

Gracie Diet for Gastroesophageal Reflux Disease

Purpose of study: The Gracie Diet is thought to play an important role in the prevention of GERD. The concept behind this diet is that the consumption of proper food combinations promotes optimal health by preventing unhealthy chemical reactions in the digestive process such as fermentation and acidity.

Sponsor: Johns Hopkins University

Participation: (The the website for more specific details on inclusion and exclusion criteria)

• Age 18 years or older at registration.
• Patients with ongoing symptoms of GERD: heartburn (pyrosis) mid-sternal chest pain, regurgitation of fluid or food, development of esophageal inflammation that may lead to swallowing dysfunction, or extraesophageal manifestations (i.e. cough, bronchospasms, and hoarseness).
• Use of one of the following PPI medications: omeprazole, lansoprazole, pantoprazole, rabeprazole, esomeprazole or dexlansoprazole. And/or use of one of the following H2 blockers medications as well: famotidine, cimetidine, ranitidine or nizatidine.
• Willing to comply with the Gracie diet regimen

Start date: November 13, 2020

Completion date: November 1, 2022

Contact: 

• Pankaj Pasricha, MD 410-550-1793 pasricha@jhu.edu
• Guillermo Barahona, MD 410-550-8871 gbaraho1@jhmi.edu

NCT04360252

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/

_{Added September 2020}

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Functional Heartburn

**Currently no active studies**

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Rumination Syndrome

Added May 2021

Community Survey of Rumination Syndrome

Purpose of Trial: Enrolling adults over 18 years old (of any sex) who believe they have or have had rumination syndrome symptoms to help us learn more about this condition and improve diagnostic and treatment option

Participation:

• Believe they have or have had rumination syndrome symptoms
• 18 years or older of age (of any sex)
• Have access to a computer with internet access
• Ability to understand and complete all study-related materials and questionnaires
• Capable of providing consent for themselves

Study Start Date: 1/22/2020

Study End Date: 1/14/2023

Contact: Fatima Rao at frao@mgh.harvard.edu 

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Gastroparesis

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:
  1. Gastrointestinal symptoms felt to be consistent with gastroparesis within 6 months prior to Screening; AND
  2. 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

NCT05832151

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:

1. Outpatient diabetic gastroparesis patients with refractory symptoms and total ANMS GCSI score ≥ 2.0;
2. Men or women age less than 85;
3. No known mucosal disease;
4. Speak, write, and understand English (by self-report);
5. 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:

1. Postsurgical gastroparesis or prior gastric surgery (fundoplication, gastric resection or pyloroplasty);
2. Gastrointestinal obstruction, Achalasia, Chronic Intestinal Pseudo-obstruction, Colonic Inertia;
3. Use of opioids greater than 3 times a week and marijuana more than 5 times a week;
4. Change in neuromodulator dosage in last 3 months (TCA, gabapentin, olanzapine, etc.) or use of sympathomimetics;
5. Seizure history or disorder, Severe, unstable cardiac disease and arrythmias, Renal failure/dialysis;
6. Metal implants that are not MR safe, gastric electrical stimulators (GES), deep brain stimulators (DBS), sacral nerve stimulators (SNS), or pacemakers;
7. 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  

NCT05273788

Added May 2022

GI Neuromuscular Pathology Prospective Registry

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

NCT05039424  

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: 2/14/2022

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

NCT04282317 

_{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 February 2020}

Purpose of study: The purpose of the study is to evaluate the safety and efficacy of NG101 (metopimazine mesylate) when administered orally across a range of doses to participants aged 18 years or older with diabetic or idiopathic gastroparesis. Results of the study will guide optimal dose selection for phase 3.

Sponsors: Neurogastrx, Inc.

Participation:

• Adult patients with diabetic or idiopathic gastroparesis
• Symptoms consistent with gastroparesis (nausea, vomiting, early satiety, post-prandial fullness, and abdominal pain)
• Documented evidence of no mechanical obstruction
• Delayed gastric emptying as demonstrated by gastric scintigraphy or breath test

Contacts: Stephen Wax, MD info@neurogastrx.com

_{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

 

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Rare Genetic Diseases

Recruiting Individuals with Rare Genetic Disorders

Purpose of study: In an effort to help researchers working to understand gastrointestinal motility diseases like mitochondrial nueorgastrointestinal encephalopathy, blood samples and clinical data from individuals with rare genetic diseases are being collected. The samples are made anonymous and shared with scientists to use in their research for treatments and causes. Families living outside the US are also welcome to donate a sample to the repository.

Sponsors: The National Institute of General Medical Sciences (NIGMS) Human Genetic Cell Repository Program and Coriell Institute for Medical Research

Participation: Eligible individuals with an inherited genetic disease or chromosomal abnormality

Contacts: Families who want to participate in this research effort can can read more about the Repository and donation process here, or can contact the NIGMS Human Genetic Cell Repository genetic counselor, Tara Schmidlen, MS, CGC, for postage-paid sample collection kits and the necessary paperwork: Phone: 856-757-4822, Email: tschmidl@coriell.org.

_{Verified August 2017}

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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

NCT03884075  

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Pediatric Gastrointestinal Disorders

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

NCT04773158

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

NCT05287126

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 

NCT04821310

 

Added October 2022 

Psychosocial Support for Children and Young People with Gastrointestinal Diseases

Purpose of Trial: We would like to invite you and your child to help us understand what it’s like to live with a gastrointestinal condition or symptoms, and the types of support that you would find useful in routine clinic appointments. You are both invited to talk to one of our researchers, via Microsoft Teams. This conversation will be arranged at a convenient time and date for you, and will take about 60 minutes. You should only talk to us if you want to; choosing not to take part will not disadvantage you in any way. Before you decide whether you want to help us, it is important for you to understand why this project is being done. If you have any questions, you can contact us using the contact details at the end of this document.

Condition: Any gastrointestinal symptom or condition

Sponsor: University of Surrey

Start Date: Currently Open

Completion Date: February 2023

Participation:

The study is open to children and young people aged 3-16 who experience gastrointestinal symptoms and/or condition, and their families.

Contact: r.satherley@surrey.ac.uk

Added May 2022

Internet Based Cognitive Behavioral Therapy in Pediatric Chronic Pancreatitis

Purpose of study: Abdominal pain is common in children with chronic and acute recurring pancreatitis (CP, ARP), and as they continue into adulthood, the disease progresses with increased pain and greater exposure to opioids. Despite the relevancy of early pain self-management for childhood pancreatitis, there have been no studies of non-pharmacological pain intervention in this population. The proposed project will evaluate a web-based cognitive behavioral pain management program delivered to a cohort of well-phenotyped children with CP/ARP and some community participants to reduce pain, pain-related disability and enhance HRQOL; it will also identify genetic risk factors and clinical and behavioral phenotypic factors associated with treatment response to enable precision medicine approaches.

Sponsor: Seattle Children’s Hospital

Start Date: April 25, 2019

Completion Date: January 31, 2023

Participation: 

• 10-19 years old
• All sexes
• Not accepting healthly volunteers
• Diagnosed with CP or ARP
• at least 4 acute pancreatitis flare-ups/attacks in past year, or at least 1 instance of moderate (4/10 pain) pancreatitis/abdominal pain in the past month
• access to the Internet on any web-enabled device

Contacts:

• Tonya Palermo, PhD206-884-4208 tonya.palermo@seattlechildrens.org
• Homer Aalfs, BS206-884-1845 homer.aalfs@seattlechildrens.org 

NCT03707431

Celiac Disease

Added February 2023

Purpose of study:

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

1. Age 12-75 Years old
2. Has an adequate comprehension of a GFD assessed by completion of a knowledge test after viewing of educational materials.
3. 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.
4. 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.
5. 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

NCT05353985

Participants Needed for POWER-C Study

Purpose of study: The POWER-C (Promotion of Optimal Well-Being, Education, and Regulation for Celiac Disease) study is a free online, evidence-based program for people newly diagnosed and/or struggling with celiac disease. The purpose of the study is to examine the impact of an 8-week online program containing 4 modules to be completed bi-weekly in adults with celiac disease. Participants will be asked to complete online questionnaires at 4 time points.

Sponsor: University of Calgary

Participation: Adult individuals (ages 18+) located in North America diagnosed with celiac disease (blood test and/or biopsy). Eligible individuals are required to follow a strict gluten-free diet to participate.

Contact: Dr. Justine Dowd. Phone: 1-403-210-8482. Email: celiac@ucalgary.ca. For additional information: www.cureceliacdisease.org/wp-content/uploads/power_c.pdf.

_{Verified May 2018}

Chronic Intestinal Pseudo-Obstruction

*** No studies available at this time***

Irritable Bowel Syndrome (IBS)

Added June 2023

Changes in Microbiota and Quality of Life in IBS

Added February 2023

Factors Influencing the Severity in Irritable Bowel Syndrome (IBS)

Purpose of study: Undergraduate Dissertation (quantitative)

Sponsor: Brunel University

Start Date: February 1, 2023

Completion Date: March 29, 2023

Participation:

• All genders
• Adults over 18

Contact:

• Nethmi Udagama Koralalage 07983874576 nethmiu78@outlook.com
• Maridina Martinaj 0754855257 maritina.css@gmail.com

Added January 2023

Intersection of Sex and Gender Among Individuals with IBS

Purpose of Trial: The long-term objective of this study is to better understand how sex- and/or psychosocial/gender-based factors contribute to the disproportionate burden of irritable bowel syndrome (IBS) in women. Specifically, the purpose of this research study is twofold:

1.  Assess feasibility and acceptability of remote, longitudinal salivary steroid hormone measurement in women and men with IBS and women and men who serve as healthy controls (HC).
2. Assess feasibility and acceptability of virtual study visits with psychosocial/gender-based assessments among women and men with IBS and women and men who serve as HC.

Sponsor: University of South Carolina

Condition: Irritable bowel syndrome

Phase of Trial: Pilot study

Start date: January 2023

Completion date: January 2024

Type of Study:

This will be a prospective, observational study of women and men both with and without IBS. Individuals who choose to participate will attend two online/virtual study visits over the course of approximately 1 month/menstrual cycle, complete online questionnaires, daily symptom assessment, and collect four saliva samples at home which are mailed back to the University of South Carolina. Compensation is provided for study participation ($200 for HC men, $225 for men with IBS, $225 for HC women, $250 for women with IBS).

Participation:

Inclusion Criteria:

• Women and men (18-45 years of age)
• Ability to read/write in English
• Access to smartphone/computer with internet and camera
• Diagnosis of IBS and IBS subtype (for cases), with documentation provided by healthcare provider
• Willingness to participate in all study procedures

Link to to trial/ survey: https://www.sc.edu/study/colleges_schools/nursing/research/bgha.php

Contact: Dr. Kristen Weaver-Toedtman, 803-576-6352, weavertoedtmanlab@sc.edu

 

Added May 2022

Understanding the Relationship of Social Determinants of Health on Access to Low FODMAP Diet

Purpose: To understand the relationship of social determinant and access to GI nutrition

Sponsor: n/a

Start Date: Ongoing May-Mid-June 2022

Completion Date: End of July 2022

Participation: US based, 18 years or older

Contact: Kate Scarlata Kate@katescarlata.com 508-740-2956

Link to the survey

 

Purpose of the Study: This study aims to determine the most effective treatment with Transcutaneous Electrical Acustimulation (TEA) for Irritable Bowel Syndrome with Constipation (IBS-C) by comparing efficacy between 5 separate sessions. The rectum pressure as measured by a device called a barostat will be compared between visits. Each session will be testing a different combination of frequency and body position of the electrodes. Electrodes placed at either the wrist or knee will be stimulated at either 25 Hz or 100 Hz.

Sponsors: University of Michigan

Collaborators: National Institutes of Health (NIH), Transtimulation Research, Inc., National Institute of Neurological Disorders and Stroke (NINDS)

Start Date: July 15, 2021

Completion Date: July 2023

Participation: See clinical trials page for all inclusion and exclusion criteria

• 18-99 years old
• All sexes
• Not accepting healthy volunteers
• Willing to comply with all study procedures and be available for the duration of the study
• Diagnosed with IBS-C satisfying Rome IV criteria
• Have symptoms present for at least the last 3 months
• Have abdominal pain that is not adequately relieved at the time of screening and the time of randomization
• Has a VAS pain score of >3 (on 0-10 score)

Contacts:

• Jiande Chen, Ph.D. U-M Work734-764-3880 cjiande@umich.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 

NCT05083091   

Added March 2022

Purpose of study: The purpose of this study is to study the relationship between the bile acids, short chain fatty acids and bacteria within the intestines. The hypothesis is that changes in the bacterial composition of the stool are associated with the differences in bile acids and short chain fatty acids in patients having irritable bowel syndrome compared to healthy individuals.

Sponsors: Indiana University

Collaborators: NIDDK

Start Date: August 13,2019

Completion Date: September 30, 2022

Participation:

Inclusion Criteria:

• Patients with IBS, ages 18-65 fulfilling Rome IV criteria and asymptomatic controls with no prior history of GI disease or symptoms.
• Participants should be on a stable and consistent diet regimen and should not be following an extreme diet intervention such as gluten-free or a low FODMAP diet at the time of study participation.

Exclusion Criteria:

• Participants with microscopic/lymphocytic/collagenous colitis, inflammatory bowel disease, celiac disease, visceral cancer, chronic infectious disease, immunodeficiency, uncontrolled thyroid disease, history of liver disease or history of elevated AST/ALT > 2.0x the upper limit of normal
• Prior radiation therapy of the abdomen or abdominal surgeries except for C-section, tubal ligation, vaginal hysterectomy and appendectomy or cholecystectomy, > 6 months prior to study initiation.
• Ingestion of any prescription, over the counter, or herbal medications which can affect GI transit or study interpretation (e.g. opioids, narcotics, anticholinergics, norepinephrine reuptake inhibitors, nonsteroidal anti-inflammatory drugs, COX-2 inhibitors, bile acid sequestrants) within 6 months of study initiation for asymptomatic volunteers or within 2 days before study initiation for IBS patients. Rescue therapy to facilitate stool collection will be permitted where needed.
• Any females who are pregnant or trying to become pregnant or breast-feeding
• Antibiotic usage within 3 months prior to study participation
• Prebiotic or probiotic usage within the 2 weeks prior to study initiation
• Regular use of tobacco products within the past 6 months.

Contact:

• Alka Kadariya 317-278-9296 akadariy@iu.edu
• Anita Gupta 317-948-9227 ext 3179489227 anigupta@iu.edu

NCT03983434

Lifestyle Eating and Performance (LEAP) Program for the Treatment of Irritable Bowel Syndrome (IBS)

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

NCT05205785

Added January 2022

A Study Evaluating Oral Eluxadoline Administered to Pediatric Participants With Irritable Bowel Syndrome with Diarrhea (IBS-D)

Purpose of the Study: This study will assess the long-term safety of oral Eluxadoline administered to pediatric participants with IBS-D who have completed study intervention in the Phase 2 study 3030-202-002 or the Phase 3 study 3030-303-002.

Sponsor: Allergan

Start Date: August 13, 2021

Completion Date: April 28, 2028

Participation: See study for all inclusion and exclusion criteria

• 6 years to 17 years (child)
• All sexes
• No healthy volunteers

Contact: ABBVIE CALL CENTER 844-663-3742 abbvieclinicaltrials@abbvie.com

NCT04880876

Added June 2021

Acceptability and Efficacy of Zemedy App Versus Education and Relaxation Training App for IBS

Purpose of the study: The aim of the trial is to test the acceptability and efficacy of an updated digital CBT self-help app for IBS patients.  Using Zemedy 1.0 resulted in significant improvement in health-related quality of life, GI symptoms, and depression.  We hope that Zemedy 2.0 will be even more engaging and fun to use, and equally (or more) effective.   

Sponsor: Bold Health

Participation:

• Adults 18 years of age or older
• Own a smartphone
• Able to read English
• Self-report of being diagnosed by a physician with IBS

Type of Study: Experimental, randomized controlled, cross-over trial with an active control condition

Study Start Date: March 1, 2021

Study Completion Date: Estimated May 28, 2023

Contact: siipek@sas.upenn.edu

NCT04665271

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

05-19-21-0356151

Added May 2021

Purpose of the study: The objective of LIN-MD-64 is to evaluate the safety and efficacy of 12 weeks of linaclotide therapy (72 μg daily) in comparison with placebo in pediatric participants, 6 to 17 years of age, who fulfill modified Rome III Criteria for Child/Adolescent FC.

The objective of LIN-MD-64 is to evaluate the safety and efficacy of 12 weeks of linaclotide therapy (145 μg or 290 μg daily) in pediatric participants, 7 to 17 years of age, who fulfill the Rome III criteria for child/adolescent IBS and modified Rome III criteria for child/adolescent FC

Sponsor: Allergan

Participation: 

• Male and female participants must be ages 6 to 17 years (FC participants) or ages 7 to 17 years (IBS-C participants) (inclusive) at the time the participant provides assent for the study and parent/guardian/legally authorized representative (LAR) has provided signed consent.
• Participant weighs ≥18 kg at the time the participant provides assent and the parent/guardian/LAR has provided signed consent
• Participants who meet the modified Rome III criteria for Child/Adolescent FC. For at least 2 months before the Screening Visit, the participant has had 2 or fewer defecations (with each defecation occurring in the absence of any laxative, suppository, or enema use during the preceding 24 hours) in the toilet per week.

In addition, participant meets one or more of the following criteria at least once per week for at least 2 months before the screening visit:

1. History of retentive posturing or excessive volitional stool retention
2. History of painful or hard BMs 
3. History of large diameter stools that may obstruct the toilet 
4. Presence of a large fecal mass in the rectum 
5. At least 1 episode of fecal incontinence per week

• For IBS-C participants only: Participant meets Rome III criteria for child/adolescent IBS: At least once per week for at least 2 months before the Screening Visit, the participant experienced abdominal discomfort (an uncomfortable sensation not described as pain) or pain associated with 2 or more of the following at least 25% of the time:

1. 1. 1. Improvement with defecation
      2. Onset associated with a change in frequency of stool
      3. Onset associated with a change in form (appearance) of stool

• For IBS-C participants only: Participant has an average daytime abdominal pain score of ≥ 1 (at least “a tiny bit”) during the 14 days before Visit 3.
• Participant is willing to discontinue any laxatives used before the Preintervention Visit in favor of the protocol- permitted rescue medicine.
• Participant has an average of fewer than 3 SBMs per week during the 14 days before the randomization day and up to the randomization (including the morning eDiary assessments reported before administration of first dose of double-blind study intervention on the randomization day). An SBM is defined as a BM that occurs in the absence of laxative, enema, or suppository use on the calendar day of the BM or the calendar day before the BM
• Participant or parent/guardian/LAR or caregiver is compliant with eDiary requirements by completing both the morning and evening assessments for 10 out of the 14 days immediately preceding the Randomization Visit
• Female participants of childbearing potential must have a negative serum pregnancy test at the Screening Visit and a negative urine pregnancy test at the Randomization Visit prior to dosing.
• Female participants who have had their first menstrual period and are sexually active must agree to use a reliable form of contraception.
• Participant must provide written or verbal informed assent and the parent/guardian/LAR and caregiver must provide written informed consent before the initiation of any study-specific procedures
• Participant is able to read and/or understand the assessments in the eDiary device. If the participant is 6 to 11 years of age (FC participants) or 7 to 11 years of age (IBS-C participants) and does not meet this criterion, the interviewer-administered version of the eDiary must be used and the parent/guardian/LAR or caregiver who will be administering the interviewer-administered version of the eDiary must undergo training.
• Participant must have acquired toilet training skills

Contact:

• Clinical Trials Registry Team (877)-277-8566 IR-CTRegistration@Allergan.com

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 February 2020}

Purpose of study: The purpose of this study is to examine brain networks at rest in chronic pain conditions compared to healthy controls.

Sponsor: UCLA Oppenheimer Family Center for Neurobiology of Stress

Participation: Men and women between the ages of 18 and 55 who are diagnosed with IBS, right handed, not pregnant and no significant neurological or psychological medical history.

About the study: Participation involves a screening visit, an MRI and one stool sample.

Participants will be compensated up to $100 and get a digital picture of your brain.

Contact: For more information, visit www.uclacns.org/patients/clinical-research or call (310) 206-8545. You can also email Nafeesa Islam at NIslam@mednet.ucla.edu.

 

_{Updated September 2020}

Purpose of study: To provide treatment to patients with IBS-D.

Sponsor: University of Michigan and Michigan Institute for Clinical and Health Research (MICHR)

Participation: Men and women over the age of 18 diagnosed with IBS-D. Prior colonoscopy or sigmoidoscopy within the past 2 years with random colon biopsies to exclude the presence of microscopic colitis.

About the study: Patients will receive either rifaximin or low FODMAP dietary intervention.

Contact: For more information, visit https://clinicaltrials.gov/ct2/ or contact Dr. Allen Lee at (734) 936-9454, allenlee@umich.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

_{Verified August 2017}

Canadian IBS and IBD Patients Needed for IMAGINE (Inflammation, Microbiome, and Alimentation: Gastro-Intestinal and Neuropsychiatric Effects) Study

Purpose of study: The overall aim of IMAGINE Network is to understand the interactions between diet-microbiome-host and find new therapies for the treatment of IBS, IBD and associated psychiatric disorders.

Develop innovative therapies (changes in diet, probiotics, fecal transplants or antibiotics) to improve IBD, IBS and mental health
Improve outcomes of existing therapies through the assessment of diet-microbiome-host interactions
Develop strategies to optimize current therapies to target those who will most benefit from medication as well as identify those in whom medication can be safely discontinued with significant personal benefit and cost savings to the Canadian healthcare system

About The Study: Transform the management of IBD and IBS and associated mental health issues with these disorders.

Sponsor: The IMAGINE (Inflammation, Microbiome, and Alimentation: Gastro-Intestinal and Neuropsychiatric Effects) Chronic Disease Network involves 17 hospitals/universities and 75 researchers across Canada who will study the interactions between the inflammation, microbiome, diet and mental health in patients with inflammatory bowel disease (IBD) and irritable bowel syndrome (IBS).  The IMAGINE Network is one of five chronic disease networks in the SPOR (Strategy for Patient Oriented Research) initiative of CIHR (Canadian Institutes of Health Research).

Participation: Persons from across Canada are being invited to participate in the IMAGINE Network. You may be eligible to participate in this study if you have been diagnosed by your physician with Irritable Bowel Syndrome (IBS), Inflammatory Bowel Disease (IBD), including ulcerative colitis or Crohn’s disease or are a healthy individual without gastrointestinal symptoms.

You will not be eligible to participate if you have any of the following criteria:

Age under 4 years.
Past gastrointestinal bypass surgery or major bowel resections unrelated to Crohn’s disease.
Major concurrent illness such as chronic kidney disease, chronic liver disease other than primary sclerosing cholangitis, chronic immune disease unrelated to IBD.
If you have an active eating disorder such anorexia nervosa or bulimia.
If you cannot communicate in either French or English.

Due to the specific nature of this research, we require that participants have not had major gastrointestinal surgery (e.g. Roux en y, bowel resection), do not have additional disease(s) that might affect ability to participate (e.g. decompensated liver disease), prescription or non-prescription drug use that is known to cause gastrointestinal (GI) symptoms (e.g. chronic antibiotic use), fad diets or eating disorders that may cause GI symptoms.

Study Contact: Aida Fernandes, Executive Director fernaa19@mcmaster.ca or visit http://imaginespor.com/participate-in-research/

Accidental Bowel Leakage (or Incontinence)

Added November 2021

A Study to Assess the Effects of the Minnesota Medical Technologies Anal Insert Device in Fecal Incontinence

Purpose of study: The primary purpose of the study is to evaluate the effectiveness of the Minnesota Medical Technologies (MMT) anal insert device on fecal continence over 3 months in patients with fecal incontinence (FI).

Sponsor: Mayo Clinic

Start date: 05/2019

Completion Date: 06/2022

Participation: See study for all inclusion and exclusion criteria

• Male and female 
• 18 years and older at screening 

Contact: Kelly Feuerhak by email feuerhak.kelly@mayo.edu

See the Mayo Clinic website for more details

 

_{Verified August 2017}

Purpose of study: The purpose of this study is to compare 3 treatments for fecal incontinence (FI), Biofeedback (BIO), Sacral Neural Stimulation (SNS), and Injections of bulking agents (INJ) in the anal canal and rectum.

Sponsor: The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), University of North Carolina, Chapel Hill, Mayo Clinic, Colon and Rectal Surgery Associates, Ltd., Augusta University andRTI International

Participation: Physician diagnosis of FI (R15) for the past 6 months or longer, average >2 solid, liquid, or staining FI episodes per week by self-report and during the two-week baseline, meets criteria for SNS and dextranomer treatment except an internal anal sphincter defect of 120 degrees or less, able to ambulate independently on level surfaces, and less than 75% reduction in the number of FI episodes after 4 weeks of EMM.

Contact: For more information on this study, visit www.med.unc.edu/research/.

_{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:
  • Inpatient Gulf War illness group: Those with GWI that started after deployment to the Gulf War between 1990-91
  • Inpatient 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.

Colorectal Cancer

Impact Study of a Digital Solution for Patient Engagement

Purpose of study: This study aims to assess the pre-operative impact of the solution, in terms of patients’ adherence to the pre-operative program and correlations with their physical and psychological condition until their admission to surgery. The secondary purpose of the study is to precise the acceptability of the solution.

Sponsors: IHU Strasbourg

Start date: March 11, 2020

Completion: Date: Estimated October 2021

Participation: 

• 18 and older
• All sexes eligible
• Not accepting healthy volunteers
• Inclusion Criteria:
  1. Major patient candidate for a scheduled colorectal surgery and whose admission is expected within 8 days minimum
  2. Patient with an email address and an internet connection
  3. Patient able to receive and understand information about the study and give written informed consent

  Exclusion Criteria:

  1. Patient under the age of 18 years old.
  2. Pregnant or lactating patient
  3. Patient in exclusion period (determined by a previous or a current study)
  4. Patient under guardianship, trusteeship or the protection of justice

• 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.

The Effects of General Anesthetics on Lymphocytes in Patients Undergoing Colorectal Cancer Resection and Mechanism Involved

Purpose of the study: The body immunity is important to the development of tumor. The immune system is in charge of monitoring and cleaning tumor cells in circulation. Anesthesia may alter the immune response and affect the elimination of tumor cells. The purpose of the trial is to test whether inhalational anesthetic is relevant to tumor metastasis and recurrence of patients undergoing colorectal cancer resection through depression of lymphocytes-mediated immunity.

Sponsors: Guizhi Du

Start Date: September 1, 2017

Completion date: October 2023

Participation:

• 18 years to 65 years
• All Sexes
• Patients with colonal or rectal cancer undergoing cancer resection with general anesthesia

Inclusion Criteria:

• All the patients diagnosed with colonal or rectal cancer
• Aged 18-65
• ASA I-III
• Assigned to receive resection surgery under general anesthesia, with an expected duration of 2 hours or more
• Agree to participate and give signed written informed consent.

Exclusion Criteria:

• Severe organic heart, liver and kidney diseases
• Diabetes or hemopoietic disorders
• Allergy to general anesthetics
• Family historical malignant hyperthermia
• Cognition dysfunction
• End-stage cancer or with over 2 cancer metastasis, pathological results were benign tumor or TNM stage was over T1- 3N0 – 2M0
• Other primary malignant tumor
• Immune deficiency or dysfunction or autoimmune disease or long-term usage of corticoids or immunosuppressants
• Receiving general anesthesia within the last 3 months before the resection surgery
• Perioperative transfusion

Contact:

• Contact: Guizhi Du, MD, PhD +8618980602213 du_guizhi@yahoo.com
• Contact: Jin Liu, MD, PhD +86 18980601549 scujinliu@foxmail.com

NCT03193710

Functional Constipation/Chronic Idiopathic Constipation

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

NCT04838522

Added September 2021

Purpose of the study:This study consists of a 12-week double-blind, placebo-controlled part (Part A) followed by a 36-week double-blind safety extension part (Part B). Participants aged 3 to 17 years are planned for randomization in a 1:1:1 ratio to the Low Dose Group, High Dose Group, or matching placebo (placebo-controlled part [Part A]). After completion of Part A, participants in the placebo group will be re-randomized in a 1:1 ratio to the Low Dose Group or the High Dose Group (safety extension part [Part B]). Randomization at study entry will be stratified by toilet-trained status.

Sponsors: Takeda

Start date: August 2, 2021

Completion date: October 27, 2025

Participation: View study for all inclusion and exclusion criteria

• 6 months to 17 years (child)
• All sexes
• Does NOT Accepts healthy volunteers
• Participants and/or their parent(s)/caregiver(s)/legally authorized representative(s) have an understanding, ability, and willingness to fully comply with study procedures and restrictions.
• Ability to voluntarily provide written, signed, and dated (personally or via parent[s]/caregiver[s]/legally authorized representative[s]) informed consent/assent as applicable to participate in the study.

Contact:

• 1-877-825-3327 or via email at medinfoUS@takeda.com

NCT04759833

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  

NCT03842007

 

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Esophageal Cancer

Added June 2021

Esophageal Cancer Risk Registry

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)

Added May 2023

Purpose of study: The primary objective of the trial is the confirmation of the efficacy of apraglutide to evaluate the efficacy of weekly subcutaneous apraglutide in reducing parenteral support dependency.

Sponsor: VectivBio AG

Start Date: January 26, 2021

Completion Date: October 31, 2023

Participation:

Inclusion Criteria

1. Signed informed consent for this trial prior to any trial specific assessment.
2. Male and female subjects with SBS-IF, receiving parenteral support (PS), secondary to surgical resection of the small intestine with either stoma or colon-in-continuity (CIC).
3. Subject must require PS at least 3 days per work and be considered stable.
4. No restorative surgery intended to change PS requirements in the trial period.
5. Age ≥18 years at screening.

Contact: Fritze +41615513030 clinicaltrials@vectivbio.com

NCT04627025 

Added October 2022

Purpose of Survey: To add to our understanding of where and how members of the SBS/IF community access information and support; and to learn what does the community perceive to be their top unmet needs

Start date: 10/11/2022

Completion date: 11/1/2022

Participation:

Inclusion Criteria:

• Adult (18+)
• Patient with short bowel syndrome or intestinal failure OR
• Parents’ caregiver of someone living with SBS or IF

Contact for study: Marie Neumann, project researcher, University of Nebraska Center (UNMC) marie.neumann@unmc.edu 

Link to survey: https://unmcredcap.unmc.edu/redcap/surveys/?s=J3JDWAPT3LPYWCRY

Added September 2021

Purpose of the Study: The main aims of the study are to assess the safety profile of Teduglutide (Revestive®) in people with Short Bowel Disease as well as how well people respond to the treatment with Teduglutide (Revestive®).

Sponsor: Takeda

Start Date: November 5, 2020

Completion Date: November 5, 2022

Participation: See study for all inclusion and exclusion criteria

• 1 year and older (child, adult, older adult)
• All sexes
• No healthy volunteers

Contact: Takeda Contact: 1-877-825-3327 or via email medinfoUS@takeda.com

NCT04877431

Eosinophilic Esophagitis (EoE)

Added November 2022

Data and Sample Collection Study to Elucidate the Mechanisms of Eosinophilic Disorders

Added June 2022

 

 

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

NCT03980886

 

_{Added November 2020}

Outcome Measures for Eosinophilic Gastrointestinal Diseases across Ages

Purpose of study:

CEGIR is conducting this study because they want to learn more about Eosinophilic Gastrointestinal Diseases (EGIDs). As part of that goal, one area of study will compare how well a patient feels – their symptoms – with what the tissue samples look like under a microscope. The study aims to answer a series of questions, including the following:

What if the tissue looks good, but you are still experiencing symptoms?
What if the symptoms have subsided, but the eosinophil counts haven’t changed?
This study is designed to give researchers and clinicians a better idea of the correlation of symptoms to the tissue, help them find clues about the disease in the tissue samples, and assess how this information could be used in the future to help guide diagnosis and treatment plans.

OMEGA is a multicenter, longitudinal study of children and adults with EoE, EG, and EC.

Participation: CEGIR is conducting this study because they want to learn more about Eosinophilic Gastrointestinal Diseases (EGIDs). As part of that goal, one area of study will compare how well a patient feels – their symptoms – with what the tissue samples look like under a microscope. The study aims to answer a series of questions, including the following:

What if the tissue looks good, but you are still experiencing symptoms?
What if the symptoms have subsided, but the eosinophil counts haven’t changed?
This study is designed to give researchers and clinicians a better idea of the correlation of symptoms to the tissue, help them find clues about the disease in the tissue samples, and assess how this information could be used in the future to help guide diagnosis and treatment plans.

OMEGA is a multicenter, longitudinal study of children and adults with EoE, EG, and EC.

Contacts: To look up a contact in your state, visit here.

NCT02523118

_{Added September 2020}

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Diverticulitis

 

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

NCT04095663

 

***No clinical trials at this time***

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Dysphagia

Added June 2022

 

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 

NCT04504227 

Improving Diagnostic Standards in Dysphagia

Purpose of Study: The purpose of this research is to understand the normal function of swallowing and respiratory muscles in order to establish normal parameters. This will allow us to compare normal physiology and function of swallowing and breathing muscles to people with a medical history that would put them at risk for a swallowing problem. Our goal is to identify the best tests that can be quickly and easily administered to accurately detect swallowing impairment in adults. Involvement is limited to a single 2-hour evaluation.

Sponsors: University of Florisa

Start Date: April 27, 2021

Completion Date: July 1, 2024

Participation: See study for all inclusion and exclusion criteria

• 18 years to 90 years of age
• ALL sexes
• Accepting healthy volunteers

Contact: Amber Anderson, MS 352-427-6579 amber.anderson@phhp.ufl.edu

NCT04773184 

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Cyclic Vomiting Syndrome

*** No clinical trials at this time***

 

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Achalasia

Added January 2022

Assessment of Different Modified POEM for Achalasia

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Pancreas 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

NCT03727880

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

NCT04340141 

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.

Study of NGM120 in Subjects With Advanced Solid Tumors and Pancreatic Cancer Using Combination Therapy

Purpose of the study: Study of NGM120 in subjects with advanced solid tumors and pancreatic cancer.

Sponsor: NGM Biopharmaceuticals, Inc

Participation: (See website for more details on inclusion and exclusion criteria)

• 18 years or older (adult, other adult)
• Have histologically confirmed advanced or metastatic castration-resistant prostate cancer, bladder cancer, melanoma, non-small cell lung cancer, pancreatic cancer, colorectal cancer, gastric cancer, esophageal cancer, ovarian cancer, and head neck squamous cell carcinoma.

  OR..

  • Have histologically confirmed metastatic pancreatic adenocarcinoma. Recurrent unresectable pancreatic cancer is acceptable as long as the treatment is first-line.
• Have not received any approved chemotherapy, except in the adjuvant setting.

Start Date: October 16, 2019

Completion Date: January 2023

Contact: NGM Study Director650-243-5555, or email at ngm120@ngmbio.com 

NCT04068896 

 

 

 

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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:

1. Patients followed by one of the Investigators
2. The American Porphyria Foundation (APF)
3. Non-study Physician referrals
4. 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.
5. Medical Records Review

Inclusion Criteria:

• Individuals with a documented diagnosis of a porphyria.
• For each type of porphyria, the inclusion criteria are based on
  • 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;)
  • molecular findings documenting the identification of a mutation in a porphyria-related gene.
• In addition, an individual or a parent or guardian must be willing to give written informed consent or assent, as appropriate.
• 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:

• 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;
• 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:

• 12 years or Older
• All sexes
• Documented diagnosis of AHP, per physician’s determination

Contact:

• Alnylam Clinical Trial Information Line 1-877-ALNYLAM or via email clinicaltrials@alnylam.com

NCT04883905

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H. Pylori

Bismuth-containing Quadruple Therapy for Helicobacter Pylori Eradication

Purpose of study: The researchers collect treatment-naive H.pylori-positive patients from the outpatient clinic. The subjects were randomized to receive a 10-day or 14-day course of quadruple eradication therapy. 6-8 weeks after treatment, the subjects will re-take the 13C-urea breath test. Calculate the eradication rates, adverse reaction rates, patient compliance and cost-effectiveness index of each group.

Sponsors: Shandong University

Start Date: September 21, 2021

Completion Date: October 2023

Participation: See study for all inclusion and exclusion criteria

• 18 years to 65 years
• All sexes
• Not accepting healthy volunteers

Contact:

• Xiuli Zuo, MD,PhD 15588818685 ext 15588818685 zuoxiuli@sina.com