NCT06059716 Gluten Technology and Education for Celiac Health
| NCT ID | NCT06059716 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Columbia University |
| Condition | Celiac Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2024-10-08 |
| Primary Completion | 2027-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 200 participants in total. It began in 2024-10-08 with a primary completion date of 2027-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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).
Contact & Investigator
Benjamin Lebwohl, MD, MS
PRINCIPAL INVESTIGATOR
Columbia University
Frequently Asked Questions
Who can join the NCT06059716 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Celiac Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06059716 currently recruiting?
Yes, NCT06059716 is actively recruiting participants. Contact the research team at BL114@cumc.columbia.edu for enrollment information.
Where is the NCT06059716 trial being conducted?
This trial is being conducted at Chicago, United States, Boston, United States, New York, United States, Nashville, United States.
Who is sponsoring the NCT06059716 clinical trial?
NCT06059716 is sponsored by Columbia University. The principal investigator is Benjamin Lebwohl, MD, MS at Columbia University. The trial plans to enroll 200 participants.