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
About this trial
This is an interventional basic science trial for Celiac Disease
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 If a subject becomes pregnant she will be withdrawn from the study.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
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
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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