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Gluten Technology and Education for Celiac Health

RecruitingNAAges 18 Years - 75 YearsAllColumbia University
NCT06059716 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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).
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What it tests

  • Gluten detection technology
  • Continuous telemedicine monitoring
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Where

4 sites
University of Chicago Medical Center
Chicago, United States
Beth Israel Deaconess Medical Center
Boston, United States
Columbia University Irving Medical Center
New York, United States
Vanderbilt University Medical Center
Nashville, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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