Clinical Trials and Studies

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.

Research Highlighted in the March Digestive Health Monthly eNewsletter

All Functional GI Disorders

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: 

Inclusion 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:

  • Patients with unstable vital signs will not be included.

Contact:

NCT01034670

Evaluation of People With Gastrointestinal Disease

Purpose of Study: Patients with suspected or established acute or chronic gastrointestinal diseases are evaluated and treated in this protocol and will be screened for entry into other research protocols. This protocol serves several purposes: 1) allows for detailed inquiry into the gastrointestinal disorders of these patients and the status of other organ systems that would determine their ability to safely enroll in active Digestive Diseases Branch (DDB) research protocols; 2) allows investigators to offer clinical diagnostic testing, procedures, and treatment to patients if clinically indicated to facilitate their participation in clinical trials; 3) allows outpatient evaluation and treatment of patients with a variety of gastrointestinal diseases for the purposes of physician education in our accredited gastroenterology training program; and 4) After completion of the initial evaluation process, patients will either be offered a chance to participate in an active research protocol or, if no appropriate protocol is identified, patients may be seen long-term to follow the disease progression for potential future participation in DDB gastrointestinal studies. Recommendations for other treatment options outside of the NIH will be discussed with study patients and/or to their primary or referring physicians.

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

Participation:

  • Known or suspected gastrointestinal disorders.
  • Patients greater than or equal to 18 years of age capable of providing informed consent.
  • Existence of a referring community physician who would be able to manage care outside of the NIH.

Contact:

ClinicalTrials.gov Identifier: NCT01639924

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 June 2020

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 farinellila@mail.nih.gov 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 email precise@mq.edu.au.

Verified August 2017

Transition Experiences of Patients with Functional GI Disorders

Purpose of study: To better understand the transition care experiences of patients with pediatric-onset of functional GI disorders as they transition from pediatric to adult care.

Sponsor: Baylor College of Medicine

Participation: 1) Diagnosis of irritable bowel syndrome, functional dyspepsia, functional abdominal pain syndrome, or cyclical vomiting syndrome in pediatric care, 2) currently in adult care

Contact: For more information, contact Jordan Shapiro, MD jmshapir@bcm.edu

Added November 2020 

Are you a parent of a child with a mental health condition, a medical condition, and/or a rare disease?

Purpose of study: Participate in a Survey: https://www.surveymonkey.com Click here for the Spanish version: https://es.surveymonkey.comhttps://es.surveymonkey.com/r/2DXD5TX

Experiences in Accessing Mental Health Treatment
This online survey takes approximately 10-20 minutes and will contribute to a greater understanding of difficulties families face with the hope
of increasing families’ access to mental health services.

Sponsor: Children’s Friend, inc

Contact: Please contact Maria Martinez Calderon and Kim Hager at 508-753-5425 with further questions.

Added October 2020

Resistant Starch Blend Gastrointestinal Impact

Purpose of study: This study aims to test the hypothesis that a unique blend of resistant starches and fiber will promote gastrointestinal health, as measured by an increase in short-chain fatty acids and improvement in quality of life measures in conjunction with microbial community changes. This study specifically evaluates the impact on short-chain fatty acids and gut microbiota and the impact on quality of life from a resistant starch blend in healthy adult humans with occasional gastrointestinal distress.

Sponsor: Metagenics, Inc.

Participation:

• Generally healthy without use of interfering supplements or medications with occasional gastrointestinal symptoms like bloating or irregularity
• Age 21-65 years
• Willingness to maintain current lifestyle (diet and exercise) practices (other than avoiding or limiting alcohol)
• Willing to avoid alcohol during the study OR limit alcohol consumption to 1-2 glasses of light beer or wine for the 1-2 days after the stool collection for visits 2, 3 and 4
• Willingness to give written informed consent to participate in the study.
• Presence of minor symptoms of bloating or constipation or irregular bowel movements
• Willingness and ability to collect per the two stool test kit procedures 10 stool samples at home and ship per instructions
• Willing to have blood drawn 3 times (does not apply to those impacted by circumstances associated with COVID-19 pandemic)
• Ability to speak, read and understand English
• Ability to participate via telemedicine (phone or video calls for study visits and submit documents electronically and receive products and return unused products)

Treatment or Intervention: Dietary Supplement: Resistant Starch Blend or placebo starch

Contact: For more information please contact Kim Koch kimkoch@metagenics.com or visit https://clinicaltrials.gov/

Added April 2020 

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 hms@healthmode.co

Added May 2020

Research Study that Gathers Information About the Efficacy, Tolerability, and Accessibility of Different Tube Feeding Formulas in Patients Requiring Jejunal Tube Feedings

Purpose of study: You are invited to participate in a research study that gathers information about the efficacy, tolerability, and accessibility of different tube feeding formulas in patients requiring jejunal tube feedings. This research is to better understand the efficacy, tolerability and implementation of different tube feeding formulas. This information could help to minimize the need to trial multiple different formulas that would delay adequate nutrition. We hope to better understand the real-life patient experience on the tolerability and implementation of tube feeds in patients with various GI disorders requiring jejunal tube feedings.

In this study, you will be asked to complete an online electronic survey to assess your experience with different formulas used for your enteral nutrition. These surveys will be anonymous, voluntary, and responses will be collected in a de-identified manner. There will be no collection of patient names, email addresses, IP addresses or any other personal identifiers that could link responses back to a particular patient. Reminder e-mails will be sent out at 2-3-week intervals. We will allow 2 months in total for responses.

Sponsor: Stanford University

Participation: Your participation in this experiment to complete the online electronic survey will take on average of 5-10 minutes, maximum of 30 minutes.

Contact: If you have any questions, concerns or complaints about this research study, its procedures, risks and benefits, contact the Protocol Director, Linda Nguyen, MD at (650) 723-5135. Visit here to sign up: https://redcap.stanford.edu/surveys/?s=PRWF8CTMNK

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

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Covid-19

Added April 2021

Purpose of Trial: To understand the pattern of chronic gastrointestinal symptoms and the epidemiology of functional gastrointestinal disorders in patients after recovering form COVID-19.

Sponsor: No funding, Approved by Texas Tech University Health

Condition: Ongoing study

Treatment or Intervention: This is an online anonymous survey which should not take more than 20 minutes to complete.

Participation:

  • Any adult (≥18 years old) subject with or without history of positive COVID-19 PCR (swab) or antibody test and with or without COVID-19 symptoms can fill out the survey.
  • Patients with post-COVID gastrointestinal symptoms including diarrhea, abdominal pain, nausea and vomiting, bloating, heartburn, etc. are more encouraged to participate.

Contact for Study: For any questions, contact Mohammad Bashashati, MD or Karina Espino, MSc at: ttuhsc.elpaso.covidsurvey@ttuhsc.edu

Please participate and encourage COVID-19 survivors with ongoing Gastrointestinal symptoms to fill out this online survey. With your participation, you will help us to have a better understanding of this new entity.

Here is the link to survey: https://tinyurl.com/COVID-19-FGIDs

 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 Tearneylabtrials@partners.org
Contact: Anita Chung, RN 617-724-4515 Tearneylabtrials@partners.org

Added February 2020

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C. Difficile Infection (CDI)

Summit Therapeutics

Ridinilazole is being developed by Summit Therapeutics as a potential treatment for C. difficile infection (CDI). It’s a new antibiotic, and Summit is testing whether it can improve patient outcomes over the current standard of care, vancomycin, in two global clinical trials. In an earlier clinical trial in patients with CDI, ridinilazole was found to be superior to vancomycin in a measure called sustained clinical response, which tested if patients were cured after treatment and did not experience a recurrence within 30-days post-treatment. More information on ridinilazole can be found by visiting www.summitplc.com/our-programmes/c-difficile-infection.

Some key information about the trials:
• Each trial is expected to enroll up to 680 patients
• Patients will be randomized to receive either ridinilazole or vancomycin, and neither the patients nor the study doctors will know which drug they receive
• Participation will involve about 7 study visits over approximately 100 days to track the safety and effectiveness of each drug
• Patients who participate may be reimbursed for travel expenses associated with study site visits
• Patients must be 18 years of age or older
• Patients must have signs and symptoms of CDI, including diarrhea, in the 24 hours prior to entry in the trial and a positive toxin test on a stool sample produced within 72 hours of entry into the trial
• Patients cannot have had more than one prior episode of CDI in the previous three months or more than three episodes in the past 12 months
• Patients cannot have had more than 24 hours of CDI antibiotic treatment prior to entry into the trial
• There are additional entry criteria and considerations; the study doctors will ultimately decide whether a patient is eligible for entry into the clinical trials and the patient will be required to give consent
To see if you’re eligible to participate please visit the study enrollment site.

Updated March 2021

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Gastroesophageal Reflux Disease (GERD)

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

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 

Gastroparesis

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

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:

ClinTrial 1 17

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 Phar maceuticals, 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 medicalinformation@tpna.com

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 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 bdoran@cinrx.com 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 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

Verified September 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 laura.miriel@jhu.edu, or for more information visit here

Verified September 2020

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

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 Isabelle.BeaudryBellefeuille@uon.edu.au.

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: celiac@ucalgary.ca. 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 amilunsky@chginc.org for details.

Verified May 2018

Irritable Bowel Syndrome (IBS)

Added May 2021

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

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

Sponsor: Allergan

Participation

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

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

  1. History of retentive posturing or excessive volitional stool retention
  2. History of painful or hard BMs 
  3. History of large diameter stools that may obstruct the toilet 
  4. Presence of a large fecal mass in the rectum 
  5. At least 1 episode of fecal incontinence per week
  • For IBS-C participants only: Participant meets Rome III criteria for child/adolescent IBS: At least once per week for at least 2 months before the Screening Visit, the participant experienced abdominal discomfort (an uncomfortable sensation not described as pain) or pain associated with 2 or more of the following at least 25% of the time:
      1. 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

ClinicalTrials.gov Identifier: 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

Yoga

Purpose of study: The purpose of this research study is to determine whether a six-week yoga intervention delivered online/virtually via Zoom reduces abdominal pain among participants with irritable bowel syndrome (IBS).  The purpose of this study is also to determine if participation in the yoga intervention is associated with shifts in the gut microbiota and microbial-derived metabolites, which may differ among participants with IBS compared with healthy controls.

Sponsor: National Institute of Nursing Research, National Institutes of Health

Participation: You may be eligible to participate if you are 18 to 55 years old and are diagnosed with IBS. Individuals who choose to participate will complete three online/virtual study visits over the course of approximately 13 weeks, which will include the completion of questionnaires. Participants will also collect biospecimens (saliva and stool samples) at home during each of the three study visit intervals, which they mail back to the University of Maryland, School of Nursing (UMSON). Lastly, participants will wear a special wrist watch to measure patterns of physical activity and sleep for three, one-week intervals, and complete seven, 24-hour dietary recalls over the course of the study.

All participants receive a six-week, twice weekly, 60-minute private yoga intervention that is delivered online/virtually via Zoom, with half the participants receiving the intervention at the beginning of the study, and half receiving the intervention after waiting six weeks. All participants receive weekly emails throughout the 12-week intervention period, asking about levels of pain, medication updates, any issues and content related to the yoga intervention, and any adverse events. Participants will be mailed everything needed for study participation, including a yoga mat and two blocks, instructions and supplies for biospecimen collection, wrist watch, instructions and supplies for mailing items back to UMSON.
Compensation is provided for each research visit and associated biospecimen collection ($100 gift card) for a total of $300.

Study Contact: For more information, call Kristen Weaver at 410-706-7786, or email NRSWeaverlab@umaryland.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.

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 tpinksto@iu.edu
Contact: Anita Gupta 317-948-9227 ext 3179489227 anigupta@iu.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.

Added May 2018

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: Mimi Paz, BA 617-643-5742 mpaz3@mgh.harvard.edu
Contact: Kyle Staller, MD, MPH 617-724-6038 kstaller@mgh.harvard.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/

Added May 2020

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.

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. Refer to this study by its ClinicalTrials.gov identifier NCT04066894

added January 2020

An Innovative Rehabilitation Approach for Women with Anal Incontinence

Purpose of study: To determine whether eccentric, concentric, or isometric exercise training of the pelvic floor muscles has a positive impact on the pelvic floor muscles and reduces anal incontinence symptoms compared to traditional biofeedback training.

Sponsor: National Institute of Health (NIH) and University of California San Diego

Participation:

Inclusion Criteria:
• Women
• Aged 22 and over
• Not currently pregnant
• Ability to voluntarily contract the pelvic floor muscles
o Assessed via High Definition Anorectal Manometry (HDAM) at first visit
• FISI score between 10 and 45
o Assessed by study coordinator
• Good overall health and mobility
• No history of large or bleeding hemorrhoids
• No neurological issues affecting the pelvic floor area
• No changes in medication within the past two months

Study Start Date: September 2017. Enrollment is ongoing.

Study Completion Date: Projected December 2022.

Condition: Anal Incontinence (AI), Fecal Incontinence (FI)

Treatment or Intervention: Resistance training with fluid-filled FLIP bag inserted in the anal canal. Additional biofeedback component using FLIP imaging screen. All intervention components administered by a licensed physical therapist with specialized training in treatment of pelvic floor dysfunction.

Contact:

Principle Investigator – Lori Tuttle, PT, PhD Email: ltuttle@sdsu.edu

Study Coordinator – Jessica Swartz, PT, DPT Email: jswartz@sdsu.edu

added December 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

Check back later for studies.

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: tkarunaratne@augusta.edu)

verified September 2020

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 clinicaltransparency@shire.com. ClinicalTrials.gov identifier: NCT01990040

Added July 2018

Added May 2021

A Study of Benralizumab in Patients With Eosinophilic Esophagitis (MESSINA)

Purpose of study: The aim of this Phase 3 study is to investigate the use of benralizumab as a treatment for patients with EoE. The effect of doses of benralizumab on EoE histologic signs and symptoms will be assessed over a 52-week treatment period (including a 24-week double-blind placebo-controlled treatment period and a 28-week open-label treatment period). It is proposed that benralizumab will deplete eosinophils from GI tissue(s), improve the symptoms of dysphagia, and improve endoscopy scores as well as other markers of disease activity. Upon completion of the initial 52-week treatment period, patients will be offered an additional Open Label Extension period of at least 1 year, with benralizumab treatment and ongoing study assessments.

Sponsor: AstraZeneca

Participation: 

  • Patients 12 to 65 years of age, inclusive, at the time of signing the informed consent or assent (if applicable) form.
  • Documented previous diagnosis of EoE by endoscopy.
  • Must be symptomatic at Visit 1 (screening) and Visit 2 (randomization). A patient reported average of at least 2 days per week with an episode of dysphagia over the 4 weeks prior to the Visit 1
  • May be on background medications for EoE and related treatments during the study as long as the background medications have been stable for at least 4 weeks (8 weeks for PPI) prior to the screening and there is agreement not to change type of background medication or dosage during the run-in period and for the first 52 weeks of the study unless a change is medically indicated.
  • Negative serum pregnancy test for female patients of childbearing potential at Visit1.
  • 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: 

NCT04543409

 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 ekhoshhe@Ucsd.edu
Contact: Seema S Aceves, MD, PhD 8585342983 saceves@ucsd.edu

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

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.

Added September 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 kpullar@uw.edu

Added December 2019

ClinTrial DEBUT

Advancing Nutritional Science for Children With Functional Dyspepsia

Purpose of study: Food can often exacerbate gastrointestinal symptoms in adults and children with functional dyspepsia. However, it is unclear which foods exacerbate symptoms more than others.

Children with post-prandial distress functional dyspepsia will receive four different meals with variables being: semi-solid vs. solid and high fat vs high carbohydrate. At the time of ingestion and for up to 3 hours after each meal, subjects will rate their gastrointestinal symptoms. Comparisons of symptom onset and severity will be made for each meal.

Enrolled subjects will have undergone previous gastrointestinal evaluations: gastric emptying study and/or upper endoscopy. In addition, subjects will complete psychosocial measures: Behavioral Assessment for Children-3, childhood somatization inventory.

The first goal is to compare the severity of gastrointestinal symptoms with different composition and consistency meals. The second goal is to correlate the severity of postprandial gastrointestinal symptoms to psychosocial distress, gastric neuromotor function (emptying and accommodation), and duodenal inflammation.

Sponsor: Baylor College of Medicine

Participation: Rome IV Functional Dyspepsia with post-prandial distress

Previously completed normal upper endoscopy with duodenal biopsies and/or previously completed a gastric emptying scintigraphy study

Ages 10-17

Contacts:

Contact: Deshara Watson 832-826-2271 deshara.emerson@bcm.edu
Contact: Bruno Chumpitazi, MD chumpita@bcm.edu

ClinicalTrials.gov identifier: NCT04053049

Added September 2020

Cyclic Vomiting Syndrome

No active recruiting studies at this time

What are Phases?

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

  • Patients with gastroparesis or functional dyspepsia
  • Age 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 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 methodAbility to provide informed consentAbsence of other diseases (structural or metabolic) which could interfere with interpretation of the study results
    • Body 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)
    • 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

NCT03587142

Achalasia

Peroral Endoscopic Myotomy (POEM) for the Treatment of Achalasia (POEM)

Purpose of study: In Japan POEM has become the preferred modality for therapy of achalasia due to the excellent results and exceptional safety record. In the US, dedicated POEM devices were approved by the FDA just recently. As a result the bulk of the published data comes from Japan and very little is known regarding outcomes in US population. Therefore the investigators want to prospectively record our experience with POEM as done as part of routine medical care in US population. This will be a data recording study. All patients will receive standard medical care and no experimental interventions will be performed.

Sponsor: University of Florida

Participation:

  • Age 18 years and older
  • Scheduled to undergo POEM treatment

Contact

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