Status:
RECRUITING
Gluten Technology and Education for Celiac Health
Lead Sponsor:
Columbia University
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Celiac Disease
Eligibility:
All Genders
18-75 years
Phase:
NA
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...
Detailed Description
The proposed project addresses the need for a rigorous trial to test the effectiveness of novel gluten detection technologies as an adjunct to telemedicine to manage celiac disease in adults. Celiac d...
Eligibility Criteria
Inclusion
- 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
- Seeing a clinician at one of the four recruitment sites
- Having already had an initial dietitian visit at one of the participating celiac disease centers
Exclusion
- 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).
Key Trial Info
Start Date :
October 8 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2028
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT06059716
Start Date
October 8 2024
End Date
August 31 2028
Last Update
June 27 2025
Active Locations (4)
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1
University of Chicago Medical Center
Chicago, Illinois, United States, 60637
2
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
3
Columbia University Irving Medical Center
New York, New York, United States, 10032
4
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232