Clinical trial · Interventional
Gluten Related Disorders in Barrett's Esophagus
Mechanisms Underlying Development of Barrett's Esophagus in Patients With Gluten Related Disorders
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Barrett Esophagus | — | UNRESOLVED | — |
| Celiac Disease | — | UNRESOLVED | — |
| GERD | — | UNRESOLVED | — |
| Gluten Sensitivity | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Gluten free diet | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Subjects with GRDs
- 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.
- interventionNames
- Other: Gluten free diet
- type
- ACTIVE_COMPARATOR
- label
- Subjects without GRDs
- 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.
- interventionNames
- Other: Gluten free diet
Primary outcomes (1)
- measure
- Ratio of non-acidic to acidic reflux events
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available