survey men

Clinical studies/trials are important in finding more and better treatments. 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 Functional GI Disorders

ClinTrial 1 12

Purpose of study: Researchers at the NIH are seeking healthy volunteers for a study looking at how common antibiotics change the human microbiome. The microbiome is a collection of tiny organisms that live in and on our bodies. Changes in the microbiome may affected immune function, metabolism, and other aspects of health and disease.

Sponsor: National Institutes of Health (NIH) 

Participation: Non-smokers between the ages of 21-39 years with no chronic medical conditions are invited to participate

About the study: During this study, participants may:

  • Receive one course of either amoxicillin, azithromycin, or no antibiotic.
  • Provide blood, urine, feces, saliva, skin, and vaginal swab samples before, during, and after treatment.
  • Have about 11 outpatient visits over one year.
  • Participate in an optional sub study that includes three overnight stays in an environmentally controlled room that measures how your body uses energy.

Compensation for participation is provided.

Contact: For more information, visit www.clinicalstudies.info.nih.gov or call the NIH Clinical Center Office of Patient Recruitment at 1-866-444-1132 (TTY: 1-866-411-1010) and refer to the study number #16-I-0078..

Added December 2018

ClinTrial Alcohol

Purpose of study: An increasing body of preclinical literature suggests a role of the gut microbiota in a wide range of medical disorders, including neuropsychiatric diseases like autism, anxiety, and depression. Preliminary studies have reported alterations in microbiota composition, inflammation, and intestinal permeability in alcohol-dependent patients. However, there is little research on the association between these alterations and behavioral outcomes associated with alcohol use disorder (AUD), such as alcohol craving and drinking. The main goal is to investigate gut microbiota differences in current drinking versus abstinent individuals with AUD, and whether microbial profiles are correlated with alcohol cue-induced craving. Finally, another goal of this project will be to conduct preliminary translational bed-to-bench work using rodent models of excessive alcohol use via collaborations with basic science laboratories.

Sponsor: National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Participation: 

Current Alcohol Use Disorder (AUD) by DSM-5 criteria
Being alcohol abstinent for at least 4 weeks, with a minimum of 2 weeks in a non-protective environment at the time of study screening.
Specific For Current Drinking Group; CD

Current Alcohol Use Disorder (AUD) by DSM-5 criteria
Participants not seeking treatment for their alcohol use will be included.
Satisfying heavy drinking criteria during the 4-weeks prior to screening (i.e., for men, >14 standard drinks in any one week or greater than or equal to 4 drinks per occasion at least once per month over the past 30 days; for women, >7 drinks per week or greater than or equal to 3 drinks per occasion at least at least once per month over the past 30 days) and any drinking during the 2-day prior to signing the study-specific consent.
Specific For Healthy Control Group; HC

No current or past diagnostic of AUD by DSM-5 criteria
Moderate alcohol consumers: i.e., up to 1 drink per day on average and not meeting NIAAA criteria for:
-heavy (i.e., for men, >14 standard drinks in any one week or greater than or equal to 4 drinks per occasion at least once per month over the past 30 days; for women, >7 drinks per week or greater than or equal to 3 drinks per occasion at least at least once per month over the past 30 days)
-or binge drinking (i.e., drinking 5 or more standard drinks on the same occasion on at least 1 day in the past 30 days for both male and female)
If any answer is No , subject may not be enrolled.

Contact: Lisa A Farinelli, R.N.(301) 496-0836 This email address is being protected from spambots. You need JavaScript enabled to view it. ClinicalTrials.gov Identifier: NCT03152760

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 This email address is being protected from spambots. You need JavaScript enabled to view it..

Verified August 2017

 

HealthMode / Remote Study of an Electronic Means to Characterize Bowel Movements in Adult Populations

Purpose of study: To find out if a mobile phone application (HealthMode Stool) can serve as a useful tool to track and characterize daily bowel movements.

Sponsor: HealthMode

Participation:

Females and males over 18 years old
Willing to use their own/personal mobile phone (iPhone 6 or higher, running iOS 11 or higher) for participation
Willing to share demographic data with the sponsor of the study
Willing to follow app use instructions during the course of the study
Willing to log the bowel movement events on a daily basis with manual input of additional characteristics
Willing to complete survey instruments as described in study procedures
Willing to provide electronic informed consent
Able to read and understand the english language well enough to complete electronic informed consent

Contact: J. Jamison, L. Kvapilova This email address is being protected from spambots. You need JavaScript enabled to view it.

Added October 2019

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 Barrett's Esophagus

 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 This email address is being protected from spambots. You need JavaScript enabled to view it.
Contact: Anita Chung, RN 617-724-4515 This email address is being protected from spambots. You need JavaScript enabled to view it.

Added February 2020

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Gastroesophageal Reflux Disease (GERD)

ClinTrial 2

Purpose of study: The purpose of this study is to evaluate the safety and efficacy of IW-3718 administered to patients who continue to have persistent symptoms of gastroesophageal reflux disease (GERD), such as heartburn and regurgitation, while receiving once-daily (QD), standard-dose proton pump inhibitors (PPIs).

Sponsor: Ironwood Pharmaceuticals, Inc.

Participation: Adult patients ages 18 and older with a diagnosis of GERD and reporting persistent GERD symptoms (heartburn or regurgitation) while taking standard PPI therapy. Eligible volunteers will be given three tablets twice daily, immediately after the morning and evening meals.

79 US study locations are enrolling for this study.

Contact: For more information, visit the study listing on clinicaltrials.gov.

Added December 2018

Veterans with GERD Needed for Research Study

Purpose of study: The purpose of this study is to investigate using VUMC’s Diet, Body Composition, and Human Metabolism Core to compare the effects of diets on gastroesophageal reflux disease (GERD) in Veterans.

Sponsor: Vanderbilt University Medical Center

Participation: Veterans with GERD and BMI >/= 30

Contact: Interested participants should call 615-936-0985 or or email This email address is being protected from spambots. You need JavaScript enabled to view it.

Added April 2019

ClinTrial 2

Purpose of study: The purpose of this study is to evaluate the safety and efficacy of IW-3718 administered to patients who continue to have persistent symptoms of gastroesophageal reflux disease (GERD), such as heartburn and regurgitation, while receiving once-daily (QD), standard-dose proton pump inhibitors (PPIs).

Sponsor: Ironwood Pharmaceuticals, Inc.

Participation: Adult patients ages 18 and older with a diagnosis of GERD and reporting persistent GERD symptoms (heartburn or regurgitation) while taking standard PPI therapy. Eligible volunteers will be given three tablets twice daily, immediately after the morning and evening meals.

82 US study locations are enrolling for this study.

Contact: For more information, visit the study listing on clinicaltrials.gov.

Added December 2018

 

Gastroparesis

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Purpose of study: Primary Objective: To assess the efficacy of treatment with various dose levels of TAK-906 in adult subjects with gastroparesis compared with placebo during 12 weeks of treatment. Secondary Objectives: To evaluate the safety and tolerability of TAK-906 doses compared with placebo during 12 weeks of treatment.

Additional Objectives: • To evaluate the pharmacokinetics of TAK-906 in subjects with gastroparesis • To evaluate the effect of TAK-906 on quality of life compared with placebo. • To evaluate the potential relationship between changes in C-reactive protein (CRP), glucose-dependent insulinotropic peptide (GIP), peptide tyrosine tyrosine (PYY), clinical symptoms and motility response • To evaluate the effect of TAK-906 on GEBT.

Sponsors: Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited

Participation: Main Criteria for Inclusion:  Subject eligibility is determined according to the following criteria before entry into the study: • Adult men and women aged 18 to 85 years, inclusive, and with body mass index ≥19 to ≤40 kg/m2 inclusive. • Subjects should have symptoms of gastroparesis (eg, postprandial fullness, nausea, vomiting, upper abdominal pain, and early satiety) for at least 3 months before Screening as assessed by a physician.  • Subjects must have an average composite ANMS GCSI-DD symptom score ≥2 during the 7 days before randomization. The predominant symptom experienced by subjects must not be abdominal pain. • Subjects must experience nausea: nausea subscale (of ANMS GCSI-DD) symptom score ≥2 at least 4 of 7 days or an average nausea subscale symptom score ≥2 during the 7 days before randomization. Nausea symptoms must not be attributable to a central disorder (eg, motion sickness, glaucoma, menstrual cycles, migraine headache). • Subjects must have confirmed delayed gastric emptying at Screening: delayed gastric emptying by GEBT, defined as time to gastric half emptying (t1/2) ≥79 minutes (80th percentile). • Absence of gastric outlet obstruction confirmed by upper GI, CT, or endoscopy. Special Inclusion for Subjects with Diabetes Mellitus • Subjects must have glycosylated hemoglobin (HbA1c) ≤11% before the Randomization Visit. 

Contacts: Takeda Study Registration Call Center+1-877-825-3327 This email address is being protected from spambots. You need JavaScript enabled to view it.

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 This email address is being protected from spambots. You need JavaScript enabled to view it.

Added February 2020

ClinTrial Allergan DG

Purpose: the purpose of the study is to evaluate the safety and efficacy of relamorelin in Patients with Diabetic Gastroparesis.

Sponsors: Allergan

Study description: A 12-week, Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Evaluate the Safety and Efficacy of Relamorelin in Patients with Diabetic Gastroparesis.

Study Population:

• Males and females aged 18 and older with BMI >18.5kg/m
• Type 1 Diabetes or Type 2 Diabetes for at least 5 years duration, with controlled and stable blood glucose levels and HbA1c ≤11.0% at screening (visit 1)
• Symptoms suggestive of Diabetic Gastroparesis (DG) for at least 3 months, (e.g...Nausea, abdominal pain, post-prandial fullness, bloating, vomiting and early satiety), with mechanical obstruction of the gastrointestinal (GI) tract as the cause of symptoms having been ruled out;
• History of at least 4 vomiting episodes in the past month.

Contact information: (855) 384-7884

Added July 2019

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 This email address is being protected from spambots. You need JavaScript enabled to view it.

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 This email address is being protected from spambots. You need JavaScript enabled to view it.. For more information, please visit gpvandastudy.com 

Added July 2019

A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Efficacy, Pharmacokinetics, and Dose Response of Oral CIN-102 in Adults with Idiopathic and Diabetic Gastroparesis

Purpose: To evaluate the safety and tolerability of multiple doses of a study medication (CIN-102) in subjects with idiopathic or diabetic gastroparesis.

Sponsors: CinDome Pharma Inc., A subsidiary of CinRx Pharma, LLC

Study Population: Key Inclusion/Eligibility Criteria:

• Male and female patients ages 18 to 70 years old.

• Has a current diagnosis of idiopathic or diabetic gastroparesis defined by the following: Has gastrointestinal symptoms felt to be consistent with gastroparesis within 6 months prior to screening, or, has documented delayed gastric emptying within the past 3 years determined by gastroesophageal breath test or scintigraphy.

• Body mass index between 18 and 40 kg/m2, inclusive.

• Glycosylated hemoglobin level <11% at Screening. Other criteria apply.

Contact information: Brendan Doran This email address is being protected from spambots. You need JavaScript enabled to view it. For more information, visit https://clinicaltrials.gov/

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 This email address is being protected from spambots. You need JavaScript enabled to view it.
Contact: Cangemi David, MD 904-953-2000 This email address is being protected from spambots. You need JavaScript enabled to view it.

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 This email address is being protected from spambots. You need JavaScript enabled to view it.

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 This email address is being protected from spambots. You need JavaScript enabled to view it.

Added January 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 This email address is being protected from spambots. You need JavaScript enabled to view it.

Added January 2020

ClinTrial BESST

Purpose: This trial evaluates whether the study medication, buspirone (a 5-hydroxytryptamine (5-H T) 1a receptor agonist), improves the symptoms of gastroparesis in patients with gastroparesis symptoms and at least moderately severe symptoms of fullness and/or inability to eat a full meal. After enrollment, participants aged 18-75 years will be treated with buspirone (10 mg three times per day) or a matching placebo for 4 weeks, followed by a 2-week post-treatment washout period. The primary outcome for the study is 4-week change (week 4 minus baseline) in the 4-item postprandial fullness/early satiety subscore (higher scores indicate worse symptoms) from the Patient Assessment of Gastrointestinal Disorders Symptom Severity Index (PAGI-SYM) Gastroparesis Cardinal Symptom Index (GCSI).

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

Study Population: 1.) Age 18 to 75 years of age at initial screening interview; 2.) Symptoms compatible with gastroparesis or other functional gastric disorder for at least 3 months (does not have to be contiguous) prior to initial screening interview; 3.) Diagnosis of either diabetic or idiopathic gastroparesis; 4.) Delayed or normal gastric emptying retention on screening 4-hour Gastric Emptying Scintigraphy test; 5.) Symptoms of gastroparesis measured by the 9-item PAGI-SYM Gastroparesis Cardinal Symptom Index (GCSI) total score > 2.0 at enrollment; 6.) Symptomatic with postprandial fullness/early satiety severity at enrollment using the PAGI-SYM GCSI post-prandial fullness/early satiety subscore ≥ 3; 7.) Upper endoscopy or upper GI series without ulcers or mass lesions in the 2 years prior to enrollment

Contact information: Laura Miriel This email address is being protected from spambots. You need JavaScript enabled to view it.

Added January 2020

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Rare Genetic Diseases

Recruiting Individuals with Rare Genetic Disorders

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

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

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

Contacts: Families who want to participate in this research effort can can read more about the Repository and donation process here, or can contact the NIGMS Human Genetic Cell Repository genetic counselor, Tara Schmidlen, MS, CGC, for postage-paid sample collection kits and the necessary paperwork: Phone: 856-757-4822, Email: This email address is being protected from spambots. You need JavaScript enabled to view it..

Verified August 2017

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Pediatric Gastrointestinal Disorders

 

ClinTrial 1 22

Purpose of study: The purpose of this research study is to learn more about the relationship between children's bowel habits and the way they react to sensory input. Some children are very sensitive to the way things feel, smell, and sound, and this might interfere with their willingness to use the toilet for a bowel movement. Eligible participants will be asked to complete 4 questionnaires with questions related to these reactions to sensation and bowel habits of children.

Sponsor: University of Newcastle

Participation: Parents of children between ages 3 and 6 years. The study will include children with or without functional defecation issues who may or may not also have a diagnosis of ADHD or autism. Excluded from the study are children with organic defecation issues and/or a diagnosis other than ADHA or autism. 

Contact: Enter your information on this online contact form to receive additional study information or contact Isabelle Beaudry-Bellefeuille at This email address is being protected from spambots. You need JavaScript enabled to view it.

Added August 2017

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: This email address is being protected from spambots. You need JavaScript enabled to view it.. For additional information: www.cureceliacdisease.org/wp-content/uploads/power_c.pdf.

Verified May 2018

Chronic Intestinal Pseudo-Obstruction

Diagnostic Gene Studies for Chronic Intestinal Pseudo-Obstruction

A mutation in a gene transmitted through a dominant mode of inheritance (an affected person having a 50% risk of passing the disorder to each of his or her children) can cause chronic intestinal pseudo-obstruction (CIPO), with or without frequent bladder involvement. The disorder can also occur due to a new mutation. Thus far, the most important gene discovered with mutations is the ACTG2 gene.

A second gene is being sought by the Center for Human Genetics. Families who wish to participate in this research effort can email Aubrey Milunsky, MD at This email address is being protected from spambots. You need JavaScript enabled to view it. for details.

Verified May 2018

Irritable Bowel Syndrome (IBS)

 

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 This email address is being protected from spambots. You need JavaScript enabled to view it..

Verified May 2018

ClinTrial IBS and Diet

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.

Sponsor: Indiana University and NIDDK

Participation: 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.

Contact: For more information, visit clinicaltrials.gov/ 

Contact: Tonya Hamilton 317-278-9296 This email address is being protected from spambots. You need JavaScript enabled to view it.
Contact: Anita Gupta 317-948-9227 ext 3179489227 This email address is being protected from spambots. You need JavaScript enabled to view it.

Added February 2020

ClinTrial Leeds

Purpose of study: A placebo controlled study to determine the efficacy and mode of action of ondansetron in the treatment of irritable bowel syndrome with diarrhea.

Sponsor: University of Leeds

Participation:

Written (signed and dated) informed consent.
Considered fit for study participation.
Meeting Rome IV criteria for IBS-D
Aged ≥ 18 years
Undergone standardised workup to exclude the following alternative diagnoses:

Microscopic colitis (colonoscopy or flexible sigmoidoscopy),
Bile acid diarrhoea (SeHCAT results of > 10% or C4 results of <19 ng/ml), Note: Cholecystectomy will not be an exclusion criteria if bile acid diarrhoea has been excluded
Lactose malabsorption.
Coeliac disease (tTG or duodenal biopsy)
All patients must agree to use methods of medically acceptable forms of contraception during the study and for 90 days after completion of study drug, (e.g. implants, injectable, combined oral contraceptives, True abstinence (when this is in line with the preferred and usual lifestyle of the patient) or vasectomised partners)
For women of child bearing potential, a negative pregnancy test should be performed within 72 hours of confirmation of eligibility.
Weekly average worst pain score >= 30 on a 0 to 100 point scale.
Any stools with a consistency of 6 or 7 on the Bristol Stool Form score (BSFS) for 2 -6 day per week.

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

Contact: Catherine Olivier 0113 343 9477 This email address is being protected from spambots. You need JavaScript enabled to view it.
Contact: Suzanne Hartley 0113 343 9477 This email address is being protected from spambots. You need JavaScript enabled to view it.

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 This email address is being protected from spambots. You need JavaScript enabled to view it.

Added February 2020

Arena ClinTrial

Purpose of study: The CAPTIVATE study will evaluate how an investigational study medication called olorinab works in people with IBS who are experiencing abdominal pain.

Sponsor: Arena Pharmaceuticals, Inc.

Participation: Inclusion criteria include patients who are 18–70 years of age, have been diagnosed with IBS-C or IBS-D, and who experience abdominal pain due to IBS. Other eligibility criteria apply. Patients should visit myibspainstudy.com or talk to their doctor to discuss if the CAPTIVATE trial may be right for them.

Contact: For more information, visit myibspainstudy.com or email Sharon Skare: This email address is being protected from spambots. You need JavaScript enabled to view it.

Added October 2019

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 This email address is being protected from spambots. You need JavaScript enabled to view it..

Added May 2018

Value of diet app for increasing adherence to Low FODMAP Diet (LFD)

Purpose of study: To determine whether a novel machine learning dietary mobile application (ML-App) will improve adherence to the Low Fodmap Diet compared to a standard online dietary intervention in populations with IBS or IBS-like symptoms over a 4 week period.

Sponsor: Arizona State University GPSA and ASU Graduate College 

Participation: Subjects are between 18 and 65 years of age, own an I-phone, and had not used a dietary application or elimination diet (e.g., LFD, Specific Carbohydrate, Vegan, Vegetarian, Gluten Free) for IBS in the past 6 months. Participants must be willing to participate in the LFD intervention over a 4-week period with a monitoring period of 2-weeks. Participants will agree to complete online questionnaires as frequently as once per week from study start. Participants are eligible for the study if they had an IBS-SSS ≥ 175 (moderate to severe IBS), meet the Rome IV criteria for IBS of any type including those with IBS with constipation (IBS-C), IBS with diarrhea (IBS-D), IBS mixed typed (IBS-M), or IBS unsubtyped (IBS-U), and had symptoms for the past 3 months or greater.

About the study: Low Fodmap Diet optimized through a Machine Learning Dietary Mobile App

Contact: For more information, please visit: http://bit.ly/ASUibs Aaron Rafferty 714-944-4889 This email address is being protected from spambots. You need JavaScript enabled to view it.

Added February 2020

ClinTrial Tai Chi

Purpose of study: The purpose of the study is to evaluate the efficacy of Tai Chi practice in reducing symptoms of Irritable Bowel Syndrome with Constipation (IBS-C).

Sponsor: Massachusetts General Hospital

Participation:

  • Age 18 - 65 years
  • BMI ≤ 35
  • Rome IV criteria for IBS-C
  • Continued IBS-C throughout run-in period
  • Compliant with reporting during run-in
  • Ability to follow verbal and written instructions
  • Ability to record daily patient reported outcomes via RedCap survey
  • Ability to use the GeoPain app on a smart phone
  • Informed consent form signed by the subjects

About the study:

This is a single-center pilot study investigating the efficacy of Tai Chi practice in reducing symptoms of IBS. The investigators hope that subjects practicing Tai Chi will have reduced symptoms of IBS-C as measured through overall global symptom relief as well as the IBS-SSS, IBS-QOL, VSI, HADS, Visual Analogue Pain Scale, and changes in bloating, abdominal pain, abdominal distention, and constipation severity. The study will also use daily entries made through the GeoPain app to record trends in pain intensity.

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

Contact: Abbey Bailey, BA 617-643-5742 This email address is being protected from spambots. You need JavaScript enabled to view it.
Contact: Kyle Staller, MD, MPH 617-724-6038 This email address is being protected from spambots. You need JavaScript enabled to view it.

Added February 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, This email address is being protected from spambots. You need JavaScript enabled to view it..

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: This email address is being protected from spambots. You need JavaScript enabled to view it.

Verified August 2017

Efficacy and Safety of IBS Digital Behavioral Treatment (EASITx)

Purpose of study: EASTIx is a pivotal study comparing two self-administered behavioral treatments for IBS provided to subjects via a smartphone or tablet.  Active and sham Treatments are videos viewed every other week  for 7 sessions over a 3 month period.

About The Study: Comparison of two self-administered behavrioral interventions.

Sponsor: MetaMe Health

Participation: EASTIx is a pivotal study comparing two self-administered behavioral treatments for IBS provided to subjects via a smartphone or tablet.  Active and sham Treatments are videos viewed every other week  for 7 sessions over a 3 month period.1. Male or female, aged 18-70, 2. Confirmation of IBS diagnosis 3. Possess an iOS or Android smartphone or iOS tablet (iPad) released in 2015 or later 4. Agreement to input information about their abdominal pain and bowel movements on a daily basis into Curebase software 5. Agreement to have their anonymized data stored in the cloud for up to 2 years after the conclusion of the study and to have the data used for research purposes. 6. Agreement to maintain stable dosage of IBS medications during the course of treatment and not to add new IBS medication or stop current IBS medications unless directed to do so by the participants treating physician. Changes in treatment will be captured using a concomitant medication assessment. 7. Average "Worst Daily Pain Severity" of >3 on a 11-point numeric rating scale (NRS) over the full 28-day symptom tracking period 8. Consistent submission of Pain Severity scores via the Curebase app (data submitted on 80% or more of days in the symptom tracking window)

Study Contact: Curebase (917) 924-5957 This email address is being protected from spambots. You need JavaScript enabled to view it.

Added November 2019

ClinTrial SMART

Purpose of study: This is a pilot study to determine the efficacy of the Stress Management and Resilience Training (SMART) program in improving gastrointestinal and psychological symptoms, health-related quality of life, and satisfaction of care in patients with irritable bowel syndrome (IBS). Half of the participants will be enrolled in the SMART program initially. The other half will be placed in a self-management stress reduction program where they will read a popular stress reduction book over 12 weeks. Then they will have access to participate in the online SMART program.

Sponsor: University of California, Los Angeles

Participation:

Those with a diagnosis of IBS based on the Rome IV diagnostic criteria (recurrent abdominal pain at least once per week in the last 3 months associated with 2 of the following: related to defecation, associated with a change in stool frequency, associated with a change in stool form. Symptoms must have started 6 months prior to presentation)
Between the ages of 18 and 70
English speaking
Are able to provide written, informed consent
At least moderate IBS symptoms (based on an IBS symptom severity scale score [IBS-SSS] of 175 or higher)
At least moderate levels of perceived stress (based on a perceived stress score of 14 or higher
If receiving pharmacologic therapy for IBS, they must be on a stable dose for 30 days prior to enrollment

About the study: Validated questionnaire with 10 questions regarding respondents stress levels.

Contact: For more information, visit https://clinicaltrials.gov/ or contact Nafeesa Islam This email address is being protected from spambots. You need JavaScript enabled to view it.

Added February 2020

ClinTrial 1 27

Purpose of study:  This online survey has been constructed in order to compile written reports of IBS episodes and help the researchers gain a better understanding of the symptoms and experiences people have during an IBS episode.

About the study: Have you been diagnosed with IBS? If so, you are eligible to help out with a one-time online survey that may take up to 20 minutes to complete. This survey is completely confidential and you will not be asked any identifying information.

Sponsor: University of North Carolina – Chapel Hill and the Drossman Center for Education and Practice of Biopsychosocial Care

To participate: Click here to begin.

Study Contact: Dr. Stephan Weinland. Phone: (919) 843 – 4422, Email: This email address is being protected from spambots. You need JavaScript enabled to view it.

Verified August 2017 

 

 

Accidental Bowel Leakage (or Incontinence)

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.

ContactKelly Feuerhak (email: This email address is being protected from spambots. You need JavaScript enabled to view it. or phone: 507-255-6802), Subhankar Chakraborty (email: This email address is being protected from spambots. You need JavaScript enabled to view it. or phone: 507-255-4803), or Adil Bharucha (email: This email address is being protected from spambots. You need JavaScript enabled to view it. or phone: 507-284-2687). Refer to this study by its ClinicalTrials.gov identifier NCT02628262

Verified August 2017

ClinTrial Augusta FI

Purpose of study: Biofeedback therapy is a labor-intensive, multi-disciplinary, team approach for the management of patients with Fecal Incontinence. It is not easily available to the vast majority of patients in the community with this problem. It is therefore imperative that a more pragmatic therapeutic approach that can be administered easily in the community ought to be developed. However, whether a treatment program that is based on home-training can be just as useful as office-based training has not been evaluated. The purpose of this study is to assess whether having patients train their pelvic floor muscles at home is as effective as in-office biofeedback training.

Sponsor: Augusta University 

Participation:

  • recurrent episodes of fecal incontinence for six months
  • no mucosal disease
  • on a two week stool diary patient will report at least one episode of incontinence a week

Contact:

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

Contact: Satish Rao, MD, PhD 7067212238 This email address is being protected from spambots. You need JavaScript enabled to view it.
Contact: Rachael Parr, MPH 7067211968 This email address is being protected from spambots. You need JavaScript enabled to view it.

Added February 2020

ClinTrial 1 36

Purpose of study: Compare the treatment response with a low FODMAP vs. psyllium based on number of episodes in patients with FI and the efficacy of a low FODMAP diet vs. psyllium in patients with FI on pre-specified clinical and quality of life endpoints.

SponsorUniversity of Michigan 

Participation: Men and women between the ages of 18 and 90, experience at least 1 episode/week of unintentional loss of stool associated with diarrhea/loose stool (Bristol stool scale of 5 or greater) and meet the Rome III criteria for Functional Fecal incontinence diagnostic criteria.

Contact: Stacy Menees, MD734-936-6400, This email address is being protected from spambots. You need JavaScript enabled to view it..

Refer to this study by its ClinicalTrials.gov identifier NCT02828384.

Added May 2018

ClinTrial 1 38

Purpose of study: The UNC Center for Functional GI & Motility Disorders is in the process of validating a symptom diary that will be used in a future research study. The aim of this portion of the study is to determine if people who do and do not have accidental bowel leakage, also known as fecal incontinence, understand the diary questions and can provide feedback on the diary.

Participation in this research study will involve filling out a daily diary for four weeks and answering questionnaires before and after the research study. This research study will involve two in-person visits that will last up to 60 minutes each.

Participants can earn up to $100 for participation in this research study.

Sponsor: UNC Center for Functional GI & Motility Disorders

Participation: Individuals both with and without fecal incontinence.

Contact: Stefanie Twist (email: This email address is being protected from spambots. You need JavaScript enabled to view it.or phone: 919-843-6961)

Verified May 2018

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), Medspira, Galderma Laboratories Company

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:This email address is being protected from spambots. You need JavaScript enabled to view it.)

added April 2019

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 This email address is being protected from spambots. You need JavaScript enabled to view it.. Refer to this study by its ClinicalTrials.gov identifier NCT04066894

added January 2020

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. 

Added March 2018

Colorectal Cancer

ClinTrial Check cap

Purpose of study: To evaluate the safety, usability, and subject compliance of the C-scan system. 

Sponsor: Check-Cap Inc. 

Condition: Screening for Colorectal Cancer for average risk population 

Participation: Male or female at the age of 40-80 years' old, Subject provided signed informed consent, Subject is willing and able to comply with the specified study requirements and follow-up evaluations, and can be contacted by telephone, Subjects able and agrees to undergo colonoscopy procedure, BMI > 22 and ≤ 35., Maximum body (abdominal) circumference < 120 cm., Has at least 3 bowel movements per week, A colonoscopy procedure is pre-scheduled within 60 days.

Contact: For more information, please email This email address is being protected from spambots. You need JavaScript enabled to view it., This email address is being protected from spambots. You need JavaScript enabled to view it., This email address is being protected from spambots. You need JavaScript enabled to view it., and This email address is being protected from spambots. You need JavaScript enabled to view it.

Refer to this study by its ClinicalTrials.gov identifier NCT03735407

Added July 2019

ClinTrial 45

Sponsor: Vibrant LTD

Participation: Inclusion criteria:  1. Subjects aged 22 years and older. 2. Subjects with Chronic Idiopathic Constipation (CIC) according to Rome III criteria and who have not experienced relief of their symptoms from available therapies (osmotic and stimulant laxatives used for at least one month at recommended dose). 3. Subjects with an average of <3 Spontaneous Bowel Movements (SBM) per week. 4. Normal colonoscopy performed within 5 years prior to study participation, unless the subjects are <50 years old and without alarm signs and/or symptoms. 5. Subject signed the Informed Consent Form (ICF). 6. Female subjects must have a negative blood pregnancy test during screening, confirmed by a negative urine pregnancy test during baseline and must not be lactating prior to receiving study medication.

Contact: Tennekoon Karunaratne (email: This email address is being protected from spambots. You need JavaScript enabled to view it.)

added April 2019

Short Bowel Syndrome (SBS)

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 This email address is being protected from spambots. You need JavaScript enabled to view it.. ClinicalTrials.gov identifier: NCT01990040

Added July 2018

 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: For more information or to participate go to https://clinicaltrials.gov/

Contact: Emad Khosh hemmat, BS 8589661700 ext 226884 This email address is being protected from spambots. You need JavaScript enabled to view it.
Contact: Seema S Aceves, MD, PhD 8585342983 This email address is being protected from spambots. You need JavaScript enabled to view it.

Added February 2020

 

 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 This email address is being protected from spambots. You need JavaScript enabled to view it.

Added December 2019

ClinTrial DEBUT

What are Phases?

Value of diet app for increasing adherence to Low FODMAP Diet (LFD)

Patients with gastroparesis or functional dyspepsiaAge 18-70 yearsPatients 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 burningMust 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 methodAbility to provide informed consentAbsence of other diseases (structural or metabolic) which could interfere with interpretation of the study resultsBody mass index of 18-35 kg/m2Several medication classes, particularly those affecting gastrointestinal transit or motor functions, will be excluded, including GLP-1 receptor or amylin agonists in patients with diabetes mellitus. Stable doses of thyroid replacement, estrogen replacement, low-dose aspirin for cardioprotection, and birth control (but with adequate backup contraception, as drug interactions with birth control have not been conducted for secretin PAM) are

 

Research Awards
2019 Award Recipients
Arpana Gupta, PhD
David Levinthal, MD, PhD
Ilan Koppen, MD, PhD
2018 Award Recipients
Amaranath Karunanayake, PhD
Katja Kovacic, MD
Cristina Martinez, PhD
Ans Pauwels, PhD
2013 Award Recipients
Enrico Corazziari, MD
Jan Tack, MD, PhD
Report from Gary Mawe, PhD: The Roles of Intestinal Nerves and Serotonin in Gut Function and Dysfunction
Ashley Blackshaw, PhD
Carlo Di Lorenzo, MD
Niranga Manjuri Devanarayana, MD
Report from Lukas Van Oudenhove, PhD: Solving the Biopsychosocial Puzzle in Functional Dyspepsia
Muriel Larauche, PhD
2011 Award Recipients
Report from Ronnie Fass, MD: Sleep and Gastroesophageal Reflux Disease (GERD)
Million Mulugeta, PhD
Adrian Miranda, MD
Samuel Nurko, MD
Sudarshan Jadcherla, MD
Shaman Rajindrajith, MD
2009 Award Recipients
Satish Rao, MD
Emeran Mayer, MD
Javier Santos, MD
Report from Martin Storr, MD, PhD: Functional Gastrointestinal Disorders: New Insights in Enteric Regulation
Report From Miguel Saps, MD: Functional Abdominal Pain in Children and Adolescents
2007 Award Recipients
Report from Bruce D. Naliboff, PhD: Symptom Based Psychology for Functional Gastrointestinal Disorders
Report from Magnus Simrén, MD, PhD: Irritable Bowel Syndrome: Searching for Underlying Causes
Report from Brennan M. R. Spiegel, MD, MSHS: Diagnostic Testing in Irritable Bowel Syndrome: Theory vs. Reality
Report from Sylvie Bradesi, PhD: Role of the Central Immune System in Functional Disorders
Paul E. Hyman, MD
Report from Miranda A. L. van Tilburg, PhD: Home Based Guided Imagery to Treat Pediatric Functional Abdominal Pain
Report from Fernando Azpiroz, MD, PhD: Understanding Intestinal Gas
2005 Award Recipients
Report from Yvette Tache, PhD: Stress and Irritable Bowel Syndrome: Unraveling the Code
Report from Shaheen Hamdy, MRCP, PhD: Adult Neurogenic Dysphagia -- Disorders and Conditions that Disrupt Swallowing
Report from Michael A. Pezzone, MD, PhD: Chronic Pelvic Pain and the Overlap of Pelvic Pain Disorders
Report from Bridget R. Southwell, PhD: Research into Treatment-Resistant Constipation in Children
Report from Rachel Rosen, MD, MPH: Symptoms Arising from Non-Acid Reflux in Children
2003 Award Recipients
Report from William E. Whitehead, PhD: Summary of Clinical Research Activities
Jyoti N. Sengupta, PhD
Report from Caroline Elder Danda, PhD: Biopsychosocial Perspectives on Assessment and Treatment
Report from Terry Buchmiller-Crair, MD: Using the Fetal Gastrointestinal Tract to Overcome Neonatal Disease
Report from Dan L. Dumitrascu, MD, PhD: The Psychosocial Adjustment to Illness in Irritable Bowel Syndrome
Report from Klaus Bielefeldt, MD, PhD: Understanding Pain and Discomfort in Functional GI Disorders
Research Grants
IFFGD Competitive Grants
2014 IFFGD Idiopathic Gastroparesis Research Grants
Leo Cheng, PhD
Braden Kuo, MD, MSc
Richard McCallum, MD
2008 IFFGD Competitive Research Grants
IFFGD Noncompetitive Grants
Other Research Grant Opportunities
Funding Research
Need for Funding Research
How to Make a Difference
The State of Research at NIH & NIDDK
Clinical Trials & Studies
Guide to Randomized Clinical Trials
Clinical Trials and Studies

2020 Advocacy Event


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Join us and share your digestive health stories with Members of Congress in Washington, DC, at IFFGD's 2020 National Advocacy Event on the Hill.

Your voice can make a positive impact across Capitol Hill. 

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