Gluten Technology and Education for Celiac Health
Recruiting now · Not applicable
Conditions studied: Celiac Disease
In brief
The investigators propose to plan for a multi-center randomized controlled trial (M-RCT) to test the effectiveness of novel gluten detection technologies as an adjunct to telemedicine to manage celiac disease in newly diagnosed adults. If successful, the proposed intervention will improve mucosal recovery, promote a shift in current practice of celiac disease management toward long-term monitoring, and represent a significant step toward reducing the severe physical and psychological consequences of celiac disease.
Key facts
- Study ID
- NCT06059716
- Run by
- Columbia University
- People needed
- 200
- Starts
- 2024-10-08
- Expected to finish
- 2028-08-31
- Last updated by the study team
- 2026-06-10
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Any gender; Age 18-75 years
- Celiac disease diagnosis by serology and duodenal biopsy (corresponding to •Marsh 3 histology), adequate sampling and interpretable villus height to crypt depth ratio upon review by our study pathologist
- Diagnosed with celiac disease within 4 months of initial study screening
- Willingness to use gluten-detection technology
- Not currently using a gluten detection technology that tests for gluten in urine or stool
You may not qualify if…
- Currently pregnant or planning to become pregnant during the study
- Not planning to follow a gluten-free diet
- Concurrent participation in a clinical trial of an experimental pharmacologic agent (for any condition).
Where it is running
- University of Chicago Medical Center — Chicago, Illinois, United States (enrolling)
- Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States (enrolling)
- Columbia University Irving Medical Center — New York, New York, United States (enrolling)
- Vanderbilt University Medical Center — Nashville, Tennessee, United States (enrolling)
Full record on ClinicalTrials.gov
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