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Gluten Related Disorders in Barrett's Esophagus

Study Purpose

In a small group of people gluten, a storage protein commonly in wheat and other grains, can cause gut inflammation and symptoms like diarrhea and abdominal pain. Gluten-related disorders include celiac disease (CD) and non-celiac gluten sensitivity (NCGS) and are treated by starting a gluten free diet (GFD). Patients with CD and NCGS also more commonly experience esophageal reflux and damage to the lining of the esophagus. A potential consequence of long-standing heartburn is Barrett's esophagus (BE), a major risk factor for cancer of the esophagus. This study aims to investigate the mechanism that leads to reflux and BE in those with gluten related disorders, and to assess if a GFD is beneficial. We will study the upper gut function and reflux activity in patients with BE both with and without a GRD disorder. Testing will occur before and after a gluten free diet is instituted. The results will help inform health care providers and patients about the connection between gluten-related disorders, reflux, BE, and the role of GFD.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Aged 18 years and over - Barrett's Esophagus diagnosis based on endoscopy and esophageal biopsies - Patients able to comply to the study procedures, according to the investigator's own judgment

    Exclusion Criteria:

    - Patients who have been on a gluten free diet within the last six months - History of bariatric surgery, fundoplication, or gastrectomy (partial or complete) - Connective tissue disease - Concurrent organic GI pathology other than benign polyps, haemorrhoids, lipomas, H.
pylori infection, diverticulosis, and melanosis coli
  • - Chronic treatment with high dose opioids - Alcohol or drug abuse - Pregnant or breastfeeding women.
Women enrolling in the study will be advised to avoid pregnancy during the course of the study by using adequate birth control such as abstinence, oral contraceptive pill, barrier contraceptives (i.e condom). If a subject becomes pregnant she will be withdrawn from the study. - Concurrent systemic disease and/or laboratory abnormalities considered by investigators to be a risk or that could interfere with data collection

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT03329534
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 McMaster University
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Premysl Bercik, MD
Principal Investigator Affiliation McMaster University
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Not yet recruiting
Countries
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Celiac Disease, Barrett Esophagus, Gluten Sensitivity, GERD
Additional Details

Perhaps patient's with gluten related disorders develop Barrett's esophagus due to non-acid reflux precipitated by upper gastrointestinal motility changes that respond to a gluten free diet; whereas patients without gluten related disorders develop Barrett's due to the accepted mechanism of acid reflux. The primary objectives are to explore if patients with gluten-related disorders (CD and GS) may have an altered mechanism of developing Barrett's esophagus typified by increased alkali reflux compared to those without gluten-related disorders; and to determine if this mechanism (altered motility and increased non-acid reflux) responds to a gluten free diet. Specific objectives include assessing whether patients with GRD and Barrett's esophagus have altered esophageal reflux extent, frequency, and type (assessed by pH-impedance); altered symptom profiles; differential esophageal body and sphincter pressures (assessed by manometry); aberrant gastroduodenal motility (assessed by videofluoroscopy) in comparison to patients with BE and no GRD. Finally a gluten free diet will be instituted to assess whether a gluten-free diet alters esophageal reflux extent, frequency, and type or symptom profiles in those with BE with and without a GRD.

Arms & Interventions

Arms

Experimental: Subjects with GRDs

An intervention of a change in diet, specifically a gluten free diet taught by a health care professional will be administered for one month's time.

Active Comparator: Subjects without GRDs

An intervention of a change in diet, specifically a gluten free diet taught by a health-care professional will be administered for one month's time.

Interventions

Other: - Gluten free diet

A month long gluten free diet

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

Premysl Bercik, MD

bercikp@mcmaster.ca

905 521 2100

For additional contact information, you can also visit the trial on clinicaltrials.gov.

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