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NCT03329534
Gluten Related Disorders in Barrett's Esophagus
NA trial testing Gluten free diet in Celiac Disease in 40 participants. Status unknown.
30 September 2018
Quick facts
| Lead sponsor | McMaster University |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | basic science |
| Enrollment | 40 |
| Start date | 1 April 2018 |
| Primary completion | 30 September 2018 |
| Estimated completion | 30 December 2018 |
Drugs / interventions tested
- Gluten free diet
Conditions studied
- Celiac Disease — all drugs for Celiac Disease →
- Barrett Esophagus — all drugs for Barrett Esophagus →
- Gluten Sensitivity — all drugs for Gluten Sensitivity →
- GERD — all drugs for GERD →
Sponsor
McMaster University
Who can join
18 and older, any sex, with Celiac Disease or Barrett Esophagus. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT03329534
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03329534 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by McMaster University
- Last refreshed: 21 March 2018
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