Gluten Technology and Education for Celiac Health
NCT06059716 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200
Last updated 2025-06-27
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.
Conditions
Interventions
- BEHAVIORAL
-
Gluten detection technology
Portable technology to sense gluten after ingestion
- BEHAVIORAL
-
Continuous telemedicine monitoring
Regular follow-up with an expert dietitian
Sponsors & Collaborators
-
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
collaborator NIH - lead OTHER
Principal Investigators
-
Benjamin Lebwohl, MD, MS · Columbia University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-10-08
- Primary Completion
- 2027-08-31
- Completion
- 2028-08-31
Countries
- United States
Study Locations
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