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Gluten Related Disorders in Barrett's Esophagus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03329534
Recruitment Status : Unknown
Verified October 2017 by McMaster University.
Recruitment status was:  Not yet recruiting
First Posted : November 6, 2017
Last Update Posted : March 21, 2018
Sponsor:
Information provided by (Responsible Party):
McMaster University

Study Description
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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.


Condition or disease Intervention/treatment Phase
Celiac Disease Barrett Esophagus Gluten Sensitivity GERD Other: Gluten free diet Not Applicable

Detailed Description:

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Mechanisms Underlying Development of Barrett's Esophagus in Patients With Gluten Related Disorders
Estimated Study Start Date : April 1, 2018
Estimated Primary Completion Date : September 30, 2018
Estimated Study Completion Date : December 30, 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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.
 Other: Gluten free diet
A month long gluten free diet
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.
 Other: Gluten free diet
A month long gluten free diet


Outcome Measures
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Primary Outcome Measures :
  1. Ratio of non-acidic to acidic reflux events [ Time Frame: At study start and at one month after a gluten free diet ]
    Proportion of non-acid to acid reflux events as determined by pH-impedance


Secondary Outcome Measures :
  1. Reflux disease questionnaire [ Time Frame: At study start and one month after a gluten free diet ]
    12 questions with six choices each. Results are added such that best score is 12 and worst score is 72.

  2. Esophageal motility [ Time Frame: At study start ]
    Manometric findings of the upper and lower sphincters and esophageal body

  3. Upper gastrointestinal motility [ Time Frame: At study start ]
    Fluoroscopic findings of gastroduodenal motility

  4. Leeds short form questionnaire [ Time Frame: At study start and one month after a gluten free diet ]
    Questionnaire for dyspepsia. Nine questions with five choices each. Only eight question scores are summed. Best score is 8 and worst score is 40.

  5. Gastroesophageal reflux disease-health related quality of life instrument [ Time Frame: At study start and one month after a gluten free diet ]
    11 questions. Ten of them are summed with six choices each. The best score is 0 and the worst score is 50.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03329534


Contacts
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Contact: Premysl Bercik, MD 905 521 2100 ext 73495 bercikp@mcmaster.ca

Sponsors and Collaborators
McMaster University
Investigators
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Study Director: Premysl Bercik, MD McMaster University
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: McMaster University
ClinicalTrials.gov Identifier: NCT03329534    
Other Study ID Numbers: GRD in BE
First Posted: November 6, 2017    Key Record Dates
Last Update Posted: March 21, 2018
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Barrett Esophagus
Celiac Disease
Precancerous Conditions
Neoplasms
Esophageal Diseases
 Gastrointestinal Diseases
Digestive System Diseases
Malabsorption Syndromes
Intestinal Diseases
Metabolic Diseases