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Gluten Technology and Education for Celiac Health
Who can join
Ages 18 to 75 · All sexes
Full eligibility criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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).
About the study
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.
What is being tested
- Gluten detection technology (behavioral)
- Continuous telemedicine monitoring (behavioral)
Sponsor: Columbia University · Participants: 200 · Started: Oct 8, 2024
Contact the study team
- Benjamin Lebwohl, MD, MS · Phone: 212-305-9338
- Randi Wolf, PhD, MPH · Phone: 212-678-3912
Official record on ClinicalTrials.gov — NCT06059716
Locations in the U.S.
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.