Gluten Related Disorders in Barrett's Esophagus

NCT03329534 | Unknown

• 1 other identifier: GRD in BE
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Celiac Disease; Barrett Esophagus; Gluten Sensitivity; GERD

Outcome Measures

Primary Outcomes (1)

• Ratio of non-acidic to acidic reflux events

  Proportion of non-acid to acid reflux events as determined by pH-impedance

  At study start and at one month after a gluten free diet

Secondary Outcomes (5)

• Reflux disease questionnaire

  At study start and one month after a gluten free diet

• Esophageal motility

  At study start

• Upper gastrointestinal motility

  At study start

• Leeds short form questionnaire

  At study start and one month after a gluten free diet

• Gastroesophageal reflux disease-health related quality of life instrument

  At study start and one month after a gluten free diet

Study Arms (2)

Subjects with GRDs

EXPERIMENTAL

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.

Other: Gluten free diet

Subjects without GRDs

ACTIVE COMPARATOR

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.

Other: Gluten free diet

Interventions

Gluten free diet OTHER

A month long gluten free diet

Subjects with GRDs; Subjects without GRDs

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• McMaster University: lead

MeSH Terms

Conditions

Celiac Disease; Barrett Esophagus; Gastroesophageal Reflux

Interventions

Diet, Gluten-Free

Condition Hierarchy (Ancestors)

Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Precancerous Conditions; Neoplasms; Esophageal Diseases; Esophageal Motility Disorders; Deglutition Disorders

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Premysl Bercik, MD

  McMaster University

  STUDY DIRECTOR

Central Study Contacts

Premysl Bercik, MD

CONTACT

905 521 2100; bercikp@mcmaster.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2017
• First Posted: November 6, 2017
• Study Start: April 1, 2018
• Primary Completion: September 30, 2018
• Study Completion: December 30, 2018
• Last Updated: March 21, 2018

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share