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Clinical Trials in Israel / NCT06059716
Recruiting Not applicable

Gluten Technology and Education for Celiac Health

NCT06059716 · tracked via the Priya Life Science Israel tracker
Sponsor
Columbia University
Phase
Not applicable
Started
2024-10-08
Last updated
2026-06-10

Condition(s) studied

Celiac Disease

Investigational drug(s) / intervention(s)

Gluten detection technologyContinuous telemedicine monitoring

Gluten detection technology: Portable technology to sense gluten after ingestion

Continuous telemedicine monitoring: Regular follow-up with an expert dietitian

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
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 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).

Primary outcome measure(s)

Trial sites (4)

FacilityCityRegionStatus
University of Chicago Medical Center Chicago Illinois Recruiting
Beth Israel Deaconess Medical Center Boston Massachusetts Recruiting
Columbia University Irving Medical Center New York New York Recruiting
Vanderbilt University Medical Center Nashville Tennessee Recruiting

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Other trials for the same condition

A Phase 2a/b Study of the Efficacy and Safety of Subcutaneous Amlitelimab in Adults With Nonresponsive Celiac Disease Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06059716 on ClinicalTrials.gov ↗ ← All trials in Israel