Gluten Technology and Education for Celiac Health
Columbia University
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.
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 disease affects about 1% of the United States (U.S.) population and seroprevalence has increased up to 5-fold in the U.S. since the 1950's, with diagnosis rates continuing to rise. Morbidity can be severe and includes anemia, infertility, osteoporosis, and malignancies, which can increase all-cause mortality. The only proven therapy is a strict gluten-free diet, the management of which can be extre…
Eligibility
- Age range
- 18–75 years
- Sex
- All
- Healthy volunteers
- No
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 * Seeing a clinician at one of the four recruitment sites * Having already had an initial dietitian visit at one of the partici…
Interventions
- BehavioralGluten detection technology
Portable technology to sense gluten after ingestion
- BehavioralContinuous telemedicine monitoring
Regular follow-up with an expert dietitian
Locations (4)
- University of Chicago Medical CenterChicago, Illinois
- Beth Israel Deaconess Medical CenterBoston, Massachusetts
- Columbia University Irving Medical CenterNew York, New York
- Vanderbilt University Medical CenterNashville, Tennessee