Clinical Trials and Studies

Clinical Trials

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 2022

all GI disorders e1652273074842

Purpose of Study: To collect data and samples from people being seen and/or treated for gastrointestinal problems at NIH, to use in future research.
Sponsors: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
 
Start Date: January 4, 2022
 
Competition date: December 31, 2035
 
Participation: See the Clinical Trials site for all inclusion and exclusion criteria 
  • 18 Years and older   (Adult, Older Adult)
  • Sexes Eligible for Study:   All
  • Accepts Healthy Volunteers:   No
  • Sampling Method:   Non-Probability Sample
Contact: 

Added February 2022

Brand X Usability Study Takeda e1645707087685

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: 

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

 

Vanda Gastric Emptying e1641817985902

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 September 2021

TAK 945 e1632741498748

Purpose of study: The main aim of this study is to check for side effects from TAK-954 and whether it speeds up the recovery of gastrointestinal function after small-bowel or large-bowel resection surgery. Participants will be treated with TAK-954 before surgery and up to 10 days after surgery.

Sponsor: Takeda

Start date: March 7, 2019

Completion Date: June 2022

Participation: See study for all inclusion and exclusion criteria

  • 18 years and older
  • All sexes
  • Does NOT Accepts healthy volunteers

Contact: 

NCT03827655

 

Added June 2021

Copy of Copy of ClinTrial 1 3 e1623976811803

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

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:

NCT01034670

ClinTrial NIH Cancer and chronic illness

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

ClinTrial Omalizumab

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

ClinTrial NIH Healthy

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

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

Top of Page


Amyloidosis

Added March 2022

A Study to Evaluate Organ Level Uptake Repeatability of 124I AT-01 in Subjects With Systemic Amyloidosis (AT01-001)

Purpose of the study: This is a multicenter, open label, single arm study in subjects with amyloid light chain (AL) or amyloid transthyretin (ATTR) systemic amyloidosis with visceral amyloid deposits. This study consists of a screening period of up to 30 days; two one-day treatment periods (Day 1 and Week 6); a safety follow-up 24-48 hours after the second administration of 124I AT-01, and a safety follow-up visit 28 days after the second administration of 124I-AT-01.
 
Sponsor: Attralus, Inc.
 
Start Date: November 30, 2021
 
Completion date: August 30, 2022
 
  • Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
  • Sexes Eligible for Study:   All
  • Accepts Healthy Volunteers:   No
 Contact: 

NCT05235269

Added January 2022

Alnylam Amyloidosis Stuy e1641819226440

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: Deptember 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


Covid-19

Added January 2022

AbbVie Covid Study e1641818689838

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 

Added October 2021

A Phase 3b, Open-Label, Safety and Immunogenicity Study of SARS-CoV-2 mRNA-1273 Vaccine in Adult Solid Organ Transplant Recipients and Healthy Controls

Purpose of the study: This is an open-label study to evaluate the safety, reactogenicity, and immunogenicity of mRNA-1273 Severe Acute Respiratory Syndrome coronavirus (SARS-CoV-2) vaccine in adults with a kidney or liver solid organ transplant (SOT) and in healthy adult participants. The primary goal of the study is to evaluate the safety of mRNA-1273 and the serum antibody (Ab) responses obtained 28 days after the last dose of mRNA-1273.

Sponsor: ModernaTX, Inc.

Start Date: April 16, 2021

Completion Date: March 31, 2023

Participation: 

Contact: Moderna Clinical Trials 877-913-3286 clinicaltrials@modernatx.com 

NCT04860297

 

Top of Page


Coexisting Conditions

Study in Major Depressive Disorder With BTRX-335140 vs Placebo

Purpose of study: A proof of concept (POC) study evaluating the impact of BTRX-335140 relative to placebo on symptoms of major depressive disorder (MDD) in adult subjects with MDD and symptoms of anhedonia and anxiety following 8 weeks of double-blind treatment as assessed by the HAMD-17 Scale.

Sponsor: BlackThorn Therapeutics, Inc.

Start date: January 9, 2020

Completion date: June 2022

Participation:

Contact: Louis Wong (415) 912-9482 Louis.Wong@BlackThornrx.com

NCT04221230

Top of Page


 Barrett’s Esophagus

Added June 2021

Copy of Copy of ClinTrial 1 4 e1623977165721

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  

ClinTrial Barretts

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

Top of Page


C. Difficile Infection (CDI)

ICClinicalTrial e1630629767657

Purpose of the study: To evaluate the safety of ridinilazole in adolescent subjects and how ridinilazole is metabolized.

Sponsors: Summit Therapeutics 

Start Date: May 19, 2021

Completion Date: December 2023

Participation: See study details for all inclusion and exclusion criteria

  • Has signed informed consent by parents or legally authorized representatives and assent by the child according to local requirements (e.g., Protected Health Information [PHI]) prior to initiation of any study-mandated procedure.
  • Is aged 12 to <18 years.
  • Has signs and symptoms of CDI including diarrhea such that in the Investigator’s opinion CDI antimicrobial therapy is required. Diarrhea is defined as a change in bowel habits, with ≥3 unformed bowel movements (UBMs (5, 6 or 7 on the Bristol Stool Chart, see Appendix 5)) in the 24 h prior to randomization.
  • Has tested positive for toxin A and/or B of C. difficile in the stool determined by a positive free toxin test (using a Sponsor agreed test). The stool sample must have been produced within 72 hours prior to randomization.
  • Has a negative stool test for other pathogens than C. difficile, or a positive test that in the investigator’s judgement is not associated with clinically significant signs and symptoms of GI infection, within 48 hours of randomization. Example pathogens may be norovirus, enteroviruses (coxsackie and ECHO), enteric adenoviruses, Salmonella, Shigella, Yersinia and Campylobacter).
  • Has contraceptive measures in place as follows (see Appendix 4 for details): Male subject: Agrees to use a highly effective contraceptive method as detailed in Appendix 4 of this protocol during the treatment period and for at least 30 days after the last dose of study treatment OR Agrees to adhere to abstinence, Refrains from donating sperm during the treatment period and for at least 30 days after the last dose of study treatment. Female subject: Is not pregnant or breastfeeding and must have a documented negative pregnancy test at screening, complies with one of the following three conditions: Not a woman of childbearing potential (WOCBP) as defined in Appendix 4, A WOCBP who agrees to follow the guidance in Appendix 4 on highly effective contraceptive methods during the treatment period and for at least 30 days after the last dose of study treatment, A WOCBP adhering to abstinence.

Contact:

NCT04802837

Updated August 2021

Top of Page


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

Top of Page


Functional Heartburn

Added May 2022

Tolerability Study of Panosyl-Isomaltooligosaccharides (PIMO) and a Placebo in Subjects With Heartburn

 
Purpose of Trial: This study will be conducted as a remote un-controlled trial to evaluate the tolerability of MHS-1031 and separately the tolerability of the formulated placebo in subjects with heartburn. Candidates will have heartburn and be taking daily Proton Pump Inhibitor Medications (PPIs) at up to twice the standard OTC or prescription dosage.
 
Treatment or Intervention: Natural Dietary Supplement
 
Sponsor: Microbiome Health Sciences
 
Start Date: February 10, 2022
 
Completion date: Until fully enrolled, expected February 2023
 
Participation: For Screening Phase inclusion, subjects must meet all the following inclusion criteria to be eligible for enrollment into the study: 
  1. Subject is willing and able to participate in the study for the required duration, understand and provide signed informed consent, and agrees to undergo all protocol activities. 
  2. Subject is proficient in reading, writing, and speaking English. 
  3. Subject is able to complete all required electronic Daily RESQ-eD questionnaires, daily medication questionnaires (Screening Phase, Product/Placebo Phase, Product Phase, and Follow-up Phase), daily General Well-being questionnaire (Screening Phase Only), 4-item Patient Health Questionnaire for Depression and Anxiety (PHQ-4) (Screening Phase Day 14), and monthly Participant Global Assessment questionnaire (Product/Placebo Phase, Product Phase).  
  4. Have access to a computer/tablet/phone with internet access and active e-mail account in order to complete electronic surveys daily throughout study participation. 
  5. Males or females between 18 and 75 years of age (inclusive), with a BMI ≥ 19 and < 35 kg/m2.  
  6. Females must not be pregnant or lactating.  
  7. Female Subjects of non-childbearing potential whether surgically sterile or postmenopausal 
  8. Female Subjects of childbearing potential must agree to use adequate contraception from the time of informed consent to the last dose of study product or placebo.  
  9. Must be on stable doses of medications, if any, prescribed for chronic conditions.  
  10. Subject must be taking daily PPI (defined as 5 to 7 days per week) of no more than one type (see “a” through “f” below) at no more than twice the standard prescription dose for their specific PPI type, for 4 consecutive weeks prior to the Screening Call, selected from the following list of medications:
    1. omeprazole (no more than 40 mg/day) 
    2. esomeprazole (no more than 40 mg/day) 
    3. lansoprazole (no more than 60 mg/day) 
    4. dexlansoprazole (no more than 60 m/dayg) 
    5. pantoprazole (no more than 80 mg/day) 
    6. rabeprazole (no more than 40 mg/day) 

History of a minimum of 3 months of heartburn (ie, burning feeling behind the breastbone” and/or “pain behind your breastbone” and/or “heartburn” per questions 1, 2 or 3 of RESQ-eD).

 
Contact: Peter Swann, MD. 571-921-9928, HB@ClinicalStudyInfo.com
 
 
 

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 

Top of Page


Gastroparesis

Added August 2022

clinical trials- Augusta University

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:

Massachusetts General Hospital Contact Info:

NCT05273788

Added May 2022

GI Neuromuscular Pathology Prospective Registry

Purpose of Study: In this research study, biopsy samples will be collected to provide more insight into the underlying cause of the motility disorders, help direct further investigation into the cause of the underlying condition, provide future prognosis and predict response to gastric electrical stimulation (GES).
 
Sponsors: Indiana University
 
Start Date: December 2013
 
Competition date: December 2025
 
Participation: See the Clinical Trials site for all inclusion and exclusion criteria 
  • 6 Months to 90 Years   (Child, Adult, Older Adult)
  • Eligible for Study:   All
  • Accepts Healthy Volunteers:   Yes
  • Sampling Method:   Non-Probability Sample
Contact: 

Added April 2022

Evoke Gastroparesis Patient Awareness Study e1649957731745

Purpose of the study: This is a market research study to understand the perspectives of patients living with gastroparesis. By participating in this study, you will be able to share firsthand your experience with the diagnostic process and treatment of gastroparesis. The findings of this study will allow our pharmaceutical partner to identify what is lacking in the current gastroparesis treatment landscape to develop better products for patients with gastroparesis. The aim of this study is market research and is not promotional in any way
 
Condition: Diabetic Gastroparesis
 
Sponsor: Evoke
 
Start date: 4.14.2022
 
Completion date: 4.28.2022
 
Participation: Diabetes patients either formally diagnosed with gastroparesis, or suspected to have gastroparesis 
 
Contact: 

Added January 2022

Endoscopic Myotomy study e1641819939146

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:

NCT04282317 

Added January 2019

ClinTrial Mass GP

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

ClinTrial Neurogastrx

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

ClinTrial 1 20

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

ClinTrial Vanda

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

ClinTrial Mayo DB

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

Added February 2020

ClinTrial GP and FD

Purpose: Researchers are looking at the effects of a cannabidiol medication on stomach function in people with gastroparesis (a paralyzed stomach) and people with dyspepsia (an upset stomach caused by improper functioning of the stomach’s muscles or nerves).

Sponsors: Mayo Clinic

Study Population: 

  • Patients with gastroparesis or functional dyspepsia
  • Age 18-70 years
  • Patients will be identified from among Mayo Clinic patients.
  • Patients will have symptoms consistent with gastroparesis based on a national guideline (2) for gastroparesis (symptoms PLUS delayed gastric emptying of solids). Patients with Rome IV criteria for postprandial distress syndrome (a subset of functional dyspepsia) (35) will be selected based on gastric emptying of solids which is NOT delayed, in addition to standard FD criteria:
  • Symptoms fulfilled for the last 3 months with onset greater than 6 months before diagnosis:
  • One or more symptoms being bothersome: postprandial fullness, early satiation, epigastric pain or burning
  • Must include one or both of the following at least 3 days per week: bothersome postprandial fullness (i.e., severe enough to impact on usual activities) or bothersome early satiation (i.e., severe enough to prevent finishing a regular-size meal)
  • No evidence of organic, systemic, or metabolic disease to explain the symptoms on routine investigations.
  • Participants will have previously undergone test of gastric emptying of solids using the standardized Mayo Clinic scintigraphic method
  • Ability to provide informed consent
  • Absence of other diseases (structural or metabolic) which could interfere with interpretation of the study results
  • Body mass index of 18-35 kg/m2

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

Contact: Kayla Arndt (507) 538-6599 Arndt.Kayla@mayo.edu

Contact: Sara Linker Nord(507) 266-1999

Added February 2020

ClinTrial Gp R

Purpose: To create a new registry of patients with symptoms of gastroparesis, both those with delayed gastric emptying and patients with similar gastroparesis symptoms but normal gastric emptying, for the enhanced study of symptoms, gastric motility abnormalities, patient characteristics, and degree of morbidity; To follow a well-characterized cohort to further define the natural history and clinical course of patients with symptoms of gastroparesis – both symptoms and gastric emptying over time; To provide a reliable source for recruitment of well-characterized patients with gastroparesis for other studies including therapeutic clinical trials, pathophysiological, molecular, histopathologic, or other ancillary studies.

Sponsors: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Study Population: 1.) Symptoms of gastroparesis of at least 12 weeks’ duration with varying degrees of nausea, vomiting, early satiety, postprandial fullness; 2.) An etiology of either diabetic, idiopathic, or post-fundoplication (Nissen, Dor, or Toupet) gastroparesis or gastroparesis-like disorder (symptoms of gastroparesis but normal gastric emptying); 3.) Gastric emptying scintigraphy 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.); 3.) Negative upper endoscopy or upper radiographic GI series within 2 years of registration; 4.) Age at least 18 years at initial screening visit

Contact information: Laura Miriel laura.miriel@jhu.edu, or for more information visit here

Verified September 2020

ClinTrial GP Peds

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

 

Top of Page


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

Top of Page


Pediatric Gastrointestinal Disorders

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:

NCT03707431

Celiac Disease

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 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

 

IBS TEA e1652273920919

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:


Added April 2022

Copy of Copy of Copy of ClinTrial 1 2 e1649246377942

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

IBS Diet e1647518931692

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:

NCT03983434

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

Purpose of study: Primary Objective:

 

  • To evaluate the effectiveness of the LEAP program to improve cytokines levels for 3 months of treatment in participants with IBS.

Secondary Objective(s):

  • To evaluate the effectiveness of the LEAP program to improve gastrointestinal symptoms for 3 months of treatment in participants with IBS.
  • To evaluate the effectiveness of the LEAP program to improve in quality of life for 3 months of treatment in participants with IBS.

Condition: Irritable bowel syndrome (IBS)

Treatment or Intervention: Lifestyle Eating and Performance (LEAP) program is a multiphase tailored eating plan that is methodically prepared for individuals with irritable bowel syndrome. Foods for each phase are selected based on the degree of Leukocyte Activation Assay-MRT (LAA-MRT®) reactivity, starting with the least immune reactive foods, and subsequent foods will be added in a nutritionally balanced manner.

Phase of Trial: Phase IV

Sponsor: Oxford Biomedical Technologies, Inc.
 
Start Date: September 2021
 
Completion Date: September 1, 2022
 
Participation: 
  • Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
  • Sexes Eligible for Study:   All
  • Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Adult patients (age 18-75 years);
  • Established diagnosis of IBS as determined by Rome III or IV Criteria;
  • Have IBS of at least moderate severity [score on the IBS-SSS of > 175 (0-500) at the baseline visit];
  • Patients will be allowed to be taking medications or supplements at the initial visit, but they must be on a stable dose regimen for at least 1 month prior to enrolment;
  • Willing to follow the LEAP program for 3 months;
  • Able to give informed consent and willing to complete the study.

Exclusion:

  • Individuals with a history of inflammatory bowel disease, celiac disease, abdominal surgeries, cancer patients under treatment, kidney failure;
  • BMI of 40 or higher;
  • Pregnancy or planned pregnancy within the next three months or lactation;
  • Any serious illness considered by the investigator that will interfere with the study procedure or results; 
  • Enrollment in active clinical trial/ experimental therapy within the last 30 days;
  • Currently on another dietary treatment approach (such us FODMAP)

Visit https://www.nowleap.com/research/IBSStudy and fill out the participation request form.

Contact:

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

Patron

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. 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:

Evaluate the Safety of Linaclotide in IBS-C Patients in China (Liberty)

Purpose of Study: This is a multi-center, one arm, prospective observational study which enrolls approximately 3,000 Chinese patients in China.The study will be performed under real world clinical practice setting. Patients will be eligible for the study after taking at least one dose of linaclotide. Every patient will be followed maximum of 6 months after enrollment. Study measures will be collected at baseline and during the follow-up period. Incidence of adverse events will be employed to assess the safety and tolerability of linaclotide in Chinese patients. The treatment satisfaction will be employed to assess the impact of treatment. The Irritable Bowel Syndrome-Quality of Life Measure (IBS-QoL) will be employed to assess the patient’s quality of life.

Sponsor: AstraZeneca

Participation:

  • ≧ 18 years old
  • Provision of subject informed consent prior to any study procedures
  • Has taken at least one dose of linaclotide
  • NOT participating in any interventional study currently or during the last 3 months

Exclusion Criteria:

  • If linaclotide is contraindicated according to the product prescribing information
  • Being unable to comply with study-specified procedure
  • Has ever participated in current study before –

Contact

NCT04462900

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 2021

ClinTrial 1 24

Purpose of study: This study involves free nutrition sessions with a skilled IBS-specializing dietitian.

Sponsor: UCLA Oppenheimer Family Center for Neurobiology of Stress

Participation: Eligible male and female individuals ages 18 and older with a diagnosis of IBS with diarrhea or diarrhea with constipation (IBS-D or IBS-M). To participate, individuals must not have tried the low FODMAP diet before.

Contact: For more information, visit www.uclacns.org/patients/clinical-research or call (310) 206-1656. You may also email Nafessa Islam at NIslam@mednet.ucla.edu.

Added February 2020

Copy of ClinTrial Mexico

Purpose of study: The combination of Lactobacillus fermentum and Lactobacillus delbrueckii (Lactobacillus LB) has proven to be effective and safe for treatment of acute diarrhea in children. Also, a clinical trial in adult patients with chronic diarrhea, showed a reduction in the number of daily stools. However, the evidence is not enough regarding the efficacy and safety of Lactobacillus LB for treatment of patients with irritable bowel syndrome with predominance of diarrhea (IBS-D).

Sponsor: Hospital General de Mexico

Participation: Patients meeting Rome IV criteria for IBS-D, without specific medical treatment for the last 4 weeks prior to inclusion in this study.

Contact: For more information, visit https://clinicaltrials.gov/ or email fatimahiguera@hotmail.com

Added February 2020

ClinTrial 1 25

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

ClinTrial 1 26

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

 

ClinTrial 1 42

Purpose of study: This 12 week Phase III study will assess the efficacy and safety of a combination clonidine and colesevelam compared with placebo in women with diarrhea and urge predominant fecal incontinence.

Sponsor: NIH and Mayo Clinic

Participation: Women aged 18 to 80 years of age with diarrhea and urge predominant or combination (urge and passive) fecal incontinence for at least one year duration.

Contact: Kelly Feuerhak (email: Feuerhak.Kelly@mayo.edu or phone: 507-255-6802), Subhankar Chakraborty (email: Chakraborty.Subhankar@mayo.edu or phone: 507-255-4803), or Adil Bharucha (email:  or phone: 507-284-2687). Refer to this study by its ClinicalTrials.gov identifier NCT02628262.

Verified August 2017

ClinTrial 43

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

ClinTrial 44

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)

verified September 2020

ClinTrial Restore study

Purpose of study: This trial studies how well sacral nerve stimulation works in treating low anterior resection syndrome or fecal incontinence (the body’s passage of stool without control) in patients with rectal cancer that has spread to nearby tissues or lymph nodes, or other pelvic cancer. Sacral nerve stimulation is a permanent implant that may improve bowel functions by stimulating the nerves that control the muscles related to bowel function.

Sponsor: M.D. Anderson Cancer Center in collaboration with National Cancer Institute (NCI)

Participation:

Cohort 1: Patients with pathologically proven diagnosis of primary rectal cancer
Cohort 1: Patients who have previously undergone surgical resection and anastomosis (restorative) with curative intent treatment with or without chemoradiation
Cohort 1: Patients with T1 and T2 pathologic stage patients treated with restorative surgical resection without radiation
Cohort 1: Patients with locally advanced rectal adenocarcinoma (T3 and T4 or lymph node positive) treated with radiation and restorative surgery
Cohort 1: Patients with self-reported FI or LARS
Cohort 1: Patients must be able to speak and understand English
Cohort 1: Patients must be willing to and able to sign an approved informed consent document
Cohort 1: Patients must be >= 24 months post-resection of rectal cancer
Cohort 1: Patients must have failed prior conservative measures such as Metamucil and motility medications and already been assessed and treated in a pelvic floor rehabilitation program (biofeedback) designed to treat FI and LARS, and continue to experience significant defecatory dysfunction, allowable per principal investigator (PI) discretion
Cohort 1: Patients must be willing and able to complete Patient Reported Outcomes Questionnaires for before device placement, during the testing phase following lead placement, and after implantation of the battery
Cohort 1: Patients must be willing and able to undergo elective ARM testing to objectively measure pelvic floor function
Cohort 1: Patients who have an average resting tone < 40 mmHg (normal > 40 mmHg) and maximal tolerance < 200 milliliters (normal 200-300 milliliters) as measured by ARM
Cohort 2: Patients with pathologically proven malignancy of the pelvis, other than rectal cancer (e.g. prostate, bladder, anus, vagina, vulva, cervix, uterus, or ovary)
Cohort 2: Patients treated with standard of care radiation therapies without surgical resection
Cohort 2: Patients with self-reported FI or other defecatory dysfunction
Cohort 2: Patients must be able to speak and understand English
Cohort 2: Patients must be willing to and able to sign an approved informed consent document
Cohort 2: Patients must be >= 18 months post-pelvic chemoradiation
Cohort 2: Patients must have already been assessed and treated in a pelvic floor rehabilitation program design to treat FI or other defecatory dysfunction and continue to experience significant defecatory dysfunction
Cohort 2: Patients must be willing and able to complete Patient Reported Outcomes (PROs) and bowel and bladder diaries (Medtronic) at multiple times during the study
Cohort 2: Patients must be willing and able to undergo elective ARM testing to measure pelvic floor function
Cohort 2: Patients who have an average resting tone < 40 mmHg (normal > 40 mmHg) and maximal tolerance < 200 milliliters (normal 200-300 milliliters) as measured by ARM

Contact: Craig A. Messick 713-792-6940 cmessick@mdanderson.org

NCT04066894

Gulf War Multisymptom Illness

ClinTrial 1 39

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
Contact: Armelle Takeda, PhD +33(0)390413608 armelle.takeda@ihu-strasbourg.eu
 
 
Takeda Study e1641496239751
Purpose of the study: The main aim of the study is to check gene change in tumor tissues with an additional analysis of the data from PARADIGM Exploratory Study, which is conducted for people with advanced/recurrent colorectal cancer.

 

In the PARADIGM Exploratory Study (NCT02394834), the drug being tested in this study is called Panitumumab and the main aim of this study is to check side effect from the study treatment (mFOLFOX6 + bevacizumab versus mFOLFOX6 + panitumumab therapy) and check if the study treatment improves symptoms of advanced/recurrent colorectal cancer.

Sponsors: Takeda
 
Start Date: August 31, 2021
 
Completion Date: July 31, 2024
 
Participation:
  • 29-79 years old
  • All sexes
  • Not accepting Healthy volunteers
  • Participants enrolled in the PARADIGM Exploratory Study (NCT02394834) who have consented to the secondary use of samples and genomic data and have not withdrawn their consent.
    • Participants enrolled in the PARADIGM Exploratory Study (NCT02394834) who have consented to the secondary use of samples and genomic data and have not withdrawn their consent. Participants with sufficient surplus samples for gene expression/mutation and pathomorphologic (IHC, IF and/or ISH, etc.) analysis.
Contact: Takeda Contact +1-877-825-3327 medinfoUS@takeda.com 
 
 

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

Added January 2022

Takeda Breastfeeding Study e1641816788874

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

Functional Constipation e1632739934312

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:

NCT04759833


Understanding Disordered Defecation CT e1630668741511

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:

NCT03842007

 

Top of Page


Added June 2021

Esophageal Cancer Risk Registry

Purpose of study: The purpose of this study is to identify markers in the blood and tissue that could indicate risk factors for the development and progression of esophagus cancer. This research aims to collect medical history, blood, and tissue samples from patients who present with an esophageal disorder. Identifying genetic and behavioral risk factors involved in the development of esophageal cancer might allow for early detection and prevention. Survival and an opportunity for a cure with esophageal cancer will depend greatly on the stage of diagnosis. Tumors can develop changes in their genetic (hereditary) make-up, and these changes can sometimes be seen in normal tissues before the development of cancer. These genetic (hereditary) changes can serve as tumor markers and can be detected using methods that study changes in genetic material like DNA and RNA. The analysis of proteins can provide additional information. By identifying changes in these molecules that are different or altered in cancer, the investigators can use methods and tests for the detection of these changes.

Sponsor: University of Pittsburgh

Collaborators: National Institutes of Health (NIH) and National Cancer Institute (NCI)

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

  • Known or suspected esophageal or gastroesophageal junction malignancy
  • Known Barrett’s metaplasia
  • Clinical management of symptomatic gastroesophageal reflux disease (GERD)
  • Achalasia
  • Hiatal hernia

Start date: June 1999

Completion date: December 2050

Contact: 

  • Julie A Ward, BSN 412-647-8583 or email at wardj@upmc.edu
  • Judy Forster, BSN 412-647-8579 forsej@upmc.edu
 

Short Bowel Syndrome (SBS)

Added January 2022

Pediatric Teduglutide Registry (PTR)

Purpose of the Study:This will be a multi-center post-marketing pediatric registry study evaluating the efficacy and safety of teduglutide. This is an observational longitudinal registry of pediatric SBS patients who are using FDA approved teduglutide as per standard of care.

Sponsor: Boston Children’s Hospital

Start Date: May 18, 2021

Completion Date: August 5, 2024

Participation: See study for all inclusion and exclusion criteria

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

Contact: Lissette Jimenez, MD 6173554806 lissette.jimenez@childrens.harvard.edu

 NCT04832087

Added September 2021

Short Bowel Disease e1632741090455

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


ClinTrial 1 41

Purpose of study: Registry to evaluate the long-term safety profile for patients with SBS who are treated with teduglutide in a routine clinical setting.

Sponsor: Shire

Participation: SBS patients treated and not treated with teduglutide will be enrolled. All ages accepted. This is an observational study. Data will be collected during routine consultations and clinical staff will enter this information into a system baseline and approximately every 6 months following. Each patient will be followed for at least 10 years.

Contact: Shire contact clinicaltransparency@shire.com

NCT01990040

Added July 2018

Added June 2022

6 e1654774971996

Purpose of the study: The purpose of this observational study is to find the best measures to define how well a person with eosinophilic disorder is doing. People with EoE, EG, EGE and EC normally undergo endoscopy and/or colonoscopy where cells are collected for microscopic analysis. Treatments are then decided based on how the cells look. We are aiming to compare different tissue components such as inflammatory cell types with clinical symptoms. We want to see if scores on standard questionnaires can give us an idea how well the person is doing.
 

Sponsor: Children’s Hospital Medical Center

 
Collaborators: National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ORDR
National Center for Advancing Translational Science (NCATS)
 
Start Date: July 2015
Completion Date: December 2050
 
Participation:

Inclusion Criteria:

  • Males or females 3 years of age and older
  • Mucosal eosinophilia: EoE ≥ 15 eosinophils/HPF in the distal or proximal esophagus, EG ≥ 30 eosinophils/HPF in 5 HPF’s in the body and/or antrum, EGE ≥ 53 eosinophils/HPF in the duodenum and/or ≥ 56 eosinophils/HPF in the jejunum and/or ileum, EC ≥ 84 eosinophils/HPF from the transverse or descending colon and/or ≥ 32 eosinophils/HPF from the rectosigmoid colon or a biopsy from any colonic location with ≥ 100 eosinophils/HPF
  • Presence of symptoms is required for patients who are newly diagnosed but not required for patients who were previously diagnosed.

Exclusion Criteria:

  • History of intestinal surgery other than G tube placement
  • Enrolled in a blinded investigational study at the time of the first study visit
  • Have esophageal stricture (<3mm)
  • Have other identifiable causes for eosinophilia (except Inflammatory Bowel Disease): infections, Gastrointestinal (GI) cancer, other GI inflammatory disease (e.g., Ulcerative Colitis or Crohn’s Disease)
Contact: 
  • Heidi Poppendeck, MPH 513-803-3078 heidi.poppendeck@cchmc.org
  •  Kara Kliewer, PhD (513) 636-4821 Kara.Kliewer@cchmc.org

NCT02523118 

Added May 2022

Efficacy and Safety of Benralizumab in Patients With Eosinophilic Gastritis and/or Gastroenteritis (The HUDSON GI Study) (HUDSON GI)

Purpose of study: This is a 3-part study. Part A and B have identical designs and are randomized, double-blinded, placebo-controlled studies, which will include patients with eosinophilic gastritis and/or duodenal-only disease. Part A will be enrolled first, followed by Part B. After completing Part A or Part B, participants will continue to Part C – open-label benralizumab treatment period.

Sponsor: AstraZeneca

Start date: January 18, 2022

Completion date: March 13, 2024

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

Inclusion criteria:

  • Aged >= 12 years of age at the time of signing the ICF or informed consent or assent form.
  • Confirmed diagnosis of EG/EGE for at least 3 months prior to screening.
  • Baseline Eosinophilic gastritis, with or without duodenitis, or eosinophilic duodenitis alone confirmed by biopsy with a gastric count of ≥30 eosinophils/hpf in at least 5 hpfs and/or duodenal eosinophil count ≥30 eosinophils/hpf in at least 3 hpfs without any other cause for the gastrointestinal eosinophilia.
  • Symptoms including at least moderate abdominal pain, nausea, bloating, early satiety, and/or loss of appetite
  • Must be adherent to daily PRO assessments including at least 8 of 14 symptom assessments in the 14 days prior to randomization
  • If on background medications for EG/EGE, the medications should be stable at least 4 weeks prior to the run-in period.
  • Willing and able to comply with all study procedures and visit schedule including follow-up visits
  • Women of childbearing potential must agree to use a highly effective form of birth control (confirmed by the Investigator) from randomization throughout the study duration and within 12 weeks after last dose if IP.

Contact:

NCT05251909


Added May 2021

 

 ClinTrial EOE

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 February 2020

ClinTrial Etrasimod

Purpose of trial: The purpose of this study is to test the safety and effectiveness of etrasimod in treating EoE. Etrasimod is an investigational medication that is taken by mouth.  This medication is also being actively evaluated as a treatment for other immune-mediated inflammatory disorders of the gastrointestinal tract (ie, ulcerative colitis, Crohn’s disease).

Sponsor: Arena Pharmaceuticals, Inc.

Participation: Potential participants must be 18 to 65 years of age, have swallowing difficulties, and evidence of esophageal tissue inflammation consistent with active EoE disease.  Eligible participants may continue the same diet and proton pump inhibitor therapy while participating in this study.  For more details on eligibility criteria for this study, please visit arena.patientwing.com.

Contact: Thai Nguyen-Cleary, MD office (858) 210-4534 mobile (310) 923-0630, or visit arena.patientwing.com

NCT04682639 

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

Top of Page


 ClinTrial PCORI

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***

Top of Page


Dysphagia

Added June 2022

 

 
7 1 e1654775199683
Purpose of the study: This multi-site trial will follow a cohort of Veterans with dysphagia for 8 weeks as they undergo clinically guided oropharyngeal exercises with oropharyngeal strengthening as the primary goal. Veterans with dysphagia will be assessed at three time points: baseline, 4 weeks after treatment initiation, and 8 weeks after treatment initiation. A non-dysphagic Veteran control group will also undergo data collection at parallel time points, without completion of a treatment paradigm. The investigators will then compare patients to non-dysphagic controls using manometry, videofluoroscopy, diet assessment, functional reserve tests, and patient-reported outcome measures.

 

 

The investigators aim to 1) quantify change in pressure measures of swallowing function resulting from dysphagia treatment; 2) determine which combination of standard of care and/or pressure-based metrics best track with outcome measures; and 3) develop multimodal prognostic algorithms that predict treatment success. This research will establish a precise outcome measurement paradigm suitable for dysphagia clinical care and research, thus improving clinical confidence and paving the way for a personalized medicine approach for dysphagia rehabilitation in Veterans

 
Sponsors: VA Office of Research and Development

 

Start date: June 2021

Completion Date: September 30, 2025

Participation: 

  • 18-99 years old
  • All sexes
  • Accepting healthy volunteers

Inclusion Criteria:

Signed an informed consent form
Receive a dysphagia diagnosis by a speech-language pathologist
Must have a dysphagia treatment plan with the goal of strengthening the oropharyngeal musculature
English speaking
 
Exclusion Criteria:
history of allergic response to barium

history of allergic response to topical anesthetics

Contact:
  • Aaron F Heneghan, PhD (608) 256-1901 ext 17801 Aaron.Heneghan@va.gov
  • Jenna W Quinto, PhD (680) 256-1901 ext 17865 jenna.quinto@va.gov

NCT04569097 

Added January 2022

Dysphagia Study e1641820690255

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 


Cyclic Vomiting Syndrome

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

 

Top of Page


Achalasia

Added January 2022

Assessment of Different Modified POEM for Achalasia

Purpose of study: The aims of this study are 1) to compare the efficacy and safety of conventional myotomy (long myotomy) and modified myotomy (short myotomy) in the treatment of type I/II achalasia patients diagnosed according to Chicago Classification; 2) to compare the efficacy and safety of conventional myotomy (circular myotomy) and modified myotomy (full-thickness myotomy) in the treatment of type I/II achalasia patients; 3) to compare the efficacy and safety of conventional myotomy (non-tailored myotomy) and modified myotomy (tailored myotomy) in the treatment of type III achalasia patients.

Sponsor: Peking Union Medical College Hospital

Start Date: September 2, 2020

Completion Date: December 2027

Participation: See study for all inclusion and exclusion criteria

  • Age 14 to 70 years of age
  • ALL sexes
  • NOT accepting Healthy volunteers

Contact: Tao Guo, MD 8610-69155017 guoqiong990@126.com

NCT04578769 


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:

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 

Pivotal, Randomized, Open-label Study of Tumor Treating Fields (TTFields, 150kHz) Concomitant With Gemcitabine and Nab-paclitaxel for Front-line Treatment of Locally-advanced Pancreatic Adenocarcinoma

Purpose of Trial:The study is a prospective, randomized controlled phase III trial aimed to test the efficacy and safety of Tumor Treating Fields (TTFields) in combination with gemcitabine and nab-paclitaxel, for front line treatment of locally-advanced pancreatic adenocarcinoma.The device is an experimental, portable, battery operated device for chronic administration of alternating electric fields (termed TTFields or TTF) to the region of the malignant tumor, by means of surface, insulated electrode arrays.

Sponsor: NovoCure Ltd.

Participation: (Check website for further details on inclusion and exclusion criteria)

  • 18 years of age and older
  • Life expectancy of ≥ 3 months
  • Histological/cytological diagnosis of de novo adenocarcinoma of the pancreas
  • Unresectable, locally advanced stage disease according to the following criteria:
    • Head/uncinate process:

      1. Solid tumor contact with SMA>180°
      2. Solid tumor contact with the CA>180°
      3. Solid tumor contact with the first jejunal SMA branch
      4. Unreconstructible SMV/PV due to tumor involvement or occlusion (can be d/t tumor or bland thrombus)
      5. Contact with most proximal draining jejunal branch into SMV
    • Body and tail

      1. Solid tumor contact of >180° with the SMA or CA
      2. Solid tumor contact with the CA and aortic involvement
      3. Unreconstructible SMV/PV due to tumor involvement or occlusion (can be d/t tumor or bland thrombus)
    • No distant metastasis, including non-regional lymph node metastasis
    • No borderline resectable (per Al-Hawary MM, et al., Radiology 201414)
  • ECOG score 0-2
  • Amenable and assigned by the investigator to receive therapy with gemcitabine and nab-paclitaxel
  • Able to operate the NovoTTF-100L(P) System independently or with the help of a caregiver
  • Signed informed consent form for the study protocol

Start Date: May 10, 2018

Completion Date: September 2023

Contact: Antonia Mahnig clinicaltrials@novocure.com

NCT03377491

 

Precision Promise Platform Trial for Metastatic Pancreatic Cancer

Purpose of Trial: Precision Promise is a multi-center, seamless Phase 2/3 platform trial designed to evaluate multiple regimens in metastatic pancreatic cancer.

Sponsor: Pancreatic Cancer Action Network

Participation: (See website for more details on inclusion and exclusion criteria)
  • 18 years and older (adult, older adult)
Start Date: January 31, 2020
 
Completion date: February 20, 2024
 
Contact: (See website for contacts and locations)
 
 

Study of Pembrolizumab (MK-3475) in Participants With Advanced Solid Tumors (MK-3475-158/KEYNOTE-158)

Purpose of Trial: In this study, participants with multiple types of advanced (unresectable and/or metastatic) solid tumors who have progressed on standard of care therapy will be treated with pembrolizumab (MK-3475).

Sponsor: Merck Sharp & Dohme Corp 

Participation: (See website for more details on inclusion and exclusion criteria)
  • 18 years and older (adult, older adult)
Start Date: December 18, 2015
 
Completion date: June 18, 2026
 
Contact: Toll Free Number 1-888-577-8839 Trialsites@merck.com
 
 

Phase 2 Study of Olaparib Monotherapy in Participants With Previously Treated, Homologous Recombination Repair Mutation (HRRm) or Homologous Recombination Deficiency (HRD) Positive Advanced Cancer

Purpose of Trial: Precision Promise is a multi-center, seamless Phase 2/3 platform trial designed to evaluate multiple regimens in metastatic pancreatic cancer.

Sponsor: Merck Sharp & Dohme Corp. and AstraZeneca

Participation: (See website for more details on inclusion and exclusion criteria)
  • 18 years and older (adult, older adult)
Start Date: December 12, 2018
 
Completion Date: February 13, 2024
 
Contact: Toll Free Number 1-888-577-8839 Trialsites@merck.com
 

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 


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

ElevateCT 1 e1630696382860

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:

NCT04883905

Top of Page


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

 

Share this page
Topics of this article
Was this article helpful?

IFFGD is a nonprofit education and research organization. Our mission is to inform, assist, and support people affected by gastrointestinal disorders.

Our original content is authored specifically for IFFGD readers, in response to your questions and concerns.

If you found this article helpful, please consider supporting IFFGD with a small tax-deductible donation.

Related Information
Personal Stories
Skip to content