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Gluten Related Disorders in Barrett's Esophagus

Primary Purpose

Celiac Disease, Barrett Esophagus, Gluten Sensitivity

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Gluten free diet
Sponsored by
McMaster University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Celiac Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 If a subject becomes pregnant she will be withdrawn from the study.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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Subjects with GRDs

    Subjects without GRDs

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Reflux disease questionnaire
    12 questions with six choices each. Results are added such that best score is 12 and worst score is 72.
    Esophageal motility
    Manometric findings of the upper and lower sphincters and esophageal body
    Upper gastrointestinal motility
    Fluoroscopic findings of gastroduodenal motility
    Leeds short form questionnaire
    Questionnaire for dyspepsia. Nine questions with five choices each. Only eight question scores are summed. Best score is 8 and worst score is 40.
    Gastroesophageal reflux disease-health related quality of life instrument
    11 questions. Ten of them are summed with six choices each. The best score is 0 and the worst score is 50.

    Full Information

    First Posted
    October 18, 2017
    Last Updated
    March 20, 2018
    Sponsor
    McMaster University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03329534
    Brief Title
    Gluten Related Disorders in Barrett's Esophagus
    Official Title
    Mechanisms Underlying Development of Barrett's Esophagus in Patients With Gluten Related Disorders
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    April 1, 2018 (Anticipated)
    Primary Completion Date
    September 30, 2018 (Anticipated)
    Study Completion Date
    December 30, 2018 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    McMaster University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Celiac Disease, Barrett Esophagus, Gluten Sensitivity, GERD

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Subjects with GRDs
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Subjects without GRDs
    Arm Type
    Active Comparator
    Arm Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Gluten free diet
    Intervention Description
    A month long gluten free diet
    Primary Outcome Measure Information:
    Title
    Ratio of non-acidic to acidic reflux events
    Description
    Proportion of non-acid to acid reflux events as determined by pH-impedance
    Time Frame
    At study start and at one month after a gluten free diet
    Secondary Outcome Measure Information:
    Title
    Reflux disease questionnaire
    Description
    12 questions with six choices each. Results are added such that best score is 12 and worst score is 72.
    Time Frame
    At study start and one month after a gluten free diet
    Title
    Esophageal motility
    Description
    Manometric findings of the upper and lower sphincters and esophageal body
    Time Frame
    At study start
    Title
    Upper gastrointestinal motility
    Description
    Fluoroscopic findings of gastroduodenal motility
    Time Frame
    At study start
    Title
    Leeds short form questionnaire
    Description
    Questionnaire for dyspepsia. Nine questions with five choices each. Only eight question scores are summed. Best score is 8 and worst score is 40.
    Time Frame
    At study start and one month after a gluten free diet
    Title
    Gastroesophageal reflux disease-health related quality of life instrument
    Description
    11 questions. Ten of them are summed with six choices each. The best score is 0 and the worst score is 50.
    Time Frame
    At study start and one month after a gluten free diet

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Premysl Bercik, MD
    Phone
    905 521 2100
    Ext
    73495
    Email
    bercikp@mcmaster.ca
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Premysl Bercik, MD
    Organizational Affiliation
    McMaster University
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Gluten Related Disorders in Barrett's Esophagus

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