Using gluten detection technology and telemedicine to manage celiac disease
Gluten Technology and Education for Celiac Health
This study is testing if new gluten detection tools used with online support from dietitians can help newly diagnosed adults with celiac disease manage their condition better and improve their quality of life.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Columbia University Academic / other |
| Locations | 4 sites (Chicago, Illinois and 3 other locations) |
| Trial ID | NCT06059716 on ClinicalTrials.gov |
What this trial studies
This project aims to conduct a multi-center randomized controlled trial to evaluate the effectiveness of novel gluten detection technologies combined with telemedicine for managing celiac disease in newly diagnosed adults. The study will focus on improving mucosal recovery and promoting long-term monitoring practices in celiac disease management. Participants will utilize gluten detection technology to enhance their awareness of gluten exposure while receiving continuous support from dietitians through telemedicine. The trial addresses the challenges faced by patients in adhering to a strict gluten-free diet and aims to improve their overall quality of life.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-75 who have been diagnosed with celiac disease within the last four months and are willing to use gluten detection technology.
Not a fit: Patients who are currently pregnant, not planning to follow a gluten-free diet, or participating in another clinical trial may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly enhance the management of celiac disease and improve patients' health outcomes.
How similar studies have performed: While the approach of combining gluten detection technology with telemedicine is innovative, similar studies have shown promise in improving patient management in other chronic conditions.
Eligibility criteria
Show full inclusion / exclusion criteria
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).
Where this trial is running
Chicago, Illinois and 3 other locations
- University of Chicago Medical Center — Chicago, Illinois, United States (Recruiting)
- Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States (Recruiting)
- Columbia University Irving Medical Center — New York, New York, United States (Recruiting)
- Vanderbilt University Medical Center — Nashville, Tennessee, United States (Recruiting)
Study contacts
- Principal investigator: Benjamin Lebwohl, MD, MS — Columbia University
- Study coordinator: Benjamin Lebwohl, MD, MS
- Email: BL114@cumc.columbia.edu
- Phone: 212-305-9338
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.