Celiac DiseaseNCT03329534
Gluten Related Disorders in Barrett's Esophagus
A study testing Gluten free diet in people with Celiac Disease and Barrett Esophagus, run by McMaster University.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Celiac Disease, Barrett Esophagus, Gluten Sensitivity
- What is being tested?
- Gluten free diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2018to 30 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 If a subject becomes pregnant she will be withdrawn from the study.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 locations and contacts
No sites are listed yet.
About this study
Official title: Mechanisms Underlying Development of Barrett's Esophagus in Patients With Gluten Related Disorders
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.
Read the 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.
- Conditions
- Celiac Disease, Barrett Esophagus, Gluten Sensitivity, GERD
- Being tested
- Gluten free diet
- Medical subject headings
- Celiac Disease, Barrett Esophagus, Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gluten free dietOther
A month long gluten free diet
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Gluten free diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ratio of non-acidic to acidic reflux events
Proportion of non-acid to acid reflux events as determined by pH-impedance
Measured: At study start and at one month after a gluten free diet
Secondary outcomes (5)
Reflux disease questionnaire
12 questions with six choices each. Results are added such that best score is 12 and worst score is 72.
Measured: At study start and one month after a gluten free diet
Esophageal motility
Manometric findings of the upper and lower sphincters and esophageal body
Measured: At study start
Upper gastrointestinal motility
Fluoroscopic findings of gastroduodenal motility
Measured: At study start
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.
Measured: At study start and one month after a gluten free diet
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.
Measured: At study start and one month after a gluten free diet
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2017
- Study start1 Apr 2018 (estimated)
- Primary completion30 Sep 2018 (estimated)
- Study completion30 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Celiac DiseaseStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Premysl Bercik, MD, Study director, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03329534
- Sponsor's protocol ID
- GRD in BE
- Status last verified
- Oct 2017
- First submitted
- 18 Oct 2017
- Last updated
- 21 Mar 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanisms Underlying Development of Barrett's Esophagus in Patients With Gluten Related Disorders
- ClinicalTrials.gov ID
- NCT03329534
- Acronym / sponsor ID
- GRD in BE
- Conditions
- Celiac Disease, Barrett Esophagus, Gluten Sensitivity, GERD
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Study start
- 1 Apr 2018 (estimated)
- Primary completion
- 30 Sep 2018 (estimated)
- Study completion
- 30 Dec 2018 (estimated)
- First posted
- 6 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Subjects with GRDs | Experimental | Other: Gluten free dietAn 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. |
| Subjects without GRDs | Active comparator | Other: Gluten free dietAn 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gluten free dietA month long gluten free diet | Other | Subjects with GRDs, Subjects without GRDs |
Primary outcome
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
5 secondary outcomes
Reflux disease questionnaire
Time frame: At study start and one month after a gluten free diet
Esophageal motility
Time frame: At study start
Upper gastrointestinal motility
Time frame: At study start
Leeds short form questionnaire
Time frame: At study start and one month after a gluten free diet
Gastroesophageal reflux disease-health related quality of life instrument
Time frame: At study start and one month after a gluten free diet
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Premysl Bercik, MD study director
McMaster University
Questions about this trial
What is this clinical trial studying?
A study testing Gluten free diet in people with Celiac Disease and Barrett Esophagus, run by McMaster University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Premysl Bercik, MD (905 521 2100 ext. 73495, bercikp@mcmaster.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ratio of non-acidic to acidic reflux events (time frame: At study start and at one month after a gluten free diet). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2018.