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RECRUITINGINTERVENTIONAL

Gluten Technology and Education for Celiac Health

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 Who Should NOT Join This Trial: - 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). Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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 participating celiac disease centers 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).

Treatments Being Tested

BEHAVIORAL

Gluten detection technology

Portable technology to sense gluten after ingestion

BEHAVIORAL

Continuous telemedicine monitoring

Regular follow-up with an expert dietitian

Locations (4)

University of Chicago Medical Center
Chicago, Illinois, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Columbia University Irving Medical Center
New York, New York, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States