Gluten Technology and Education for Celiac Health
ConditionCeliac Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorColumbia University
About this trial
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
Qualifiers
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
Disqualifiers
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).
Trial design
Treatments tested in this trial
- Gluten detection technology
- Continuous telemedicine monitoring
Treatment groups
200 Participants
are divided into 2 treatment groupsSponsors and collaborators
Columbia University
Lead sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
Source ClinicalTrials.gov