Gluten Technology and Education for Celiac Health

NCT ID: NCT06059716

Last Updated: 2025-06-27

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-08
• Study Completion Date: 2028-08-31

Brief 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.

Detailed 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 extremely challenging and has been linked to diminished quality of life, including anxiety, depression, and fatigue. Despite the recommendation to see a dietitian regularly, many with celiac disease do not see one at all or have only a single session immediately post-diagnosis. The COVID-19 pandemic has catalyzed the rapid adoption of telemedicine in gastroenterology and can facilitate communication between patient and dietitian by eliminating the need to arrange face-to-face meetings at celiac disease centers, which may be at great distance. Self-monitoring with new technologies for gluten detection in urine (e.g., gluten immunogenic peptide kits) can facilitate greater individual awareness of gluten exposures, are commercially available to the public, and have been shown to be valid and reliable. Physicians and dietitians are being asked if this technology should be used, and our preliminary studies have demonstrated acceptability and feasibility, but their impact on clinical outcomes such as mucosal recovery and symptoms has not been established. This U01 proposal is for a multi-center (New York, Massachusetts, Illinois, Tennessee) randomized controlled trial (M-RCT) to assess the effectiveness and document costs of gluten detection technologies as an adjunct to telemedicine on behavioral and clinical outcomes among newly diagnosed patients with celiac disease. Participants will be randomized to receive either 1) standard of care (i.e. a one-time in-person dietitian session plus telemedicine dietitian follow-up; or 2) standard of care + gluten detection technology. This would be the first large-scale clinical trial to test the effect of self-monitoring using gluten detection technology in the management of celiac disease. The primary outcome will be mucosal recovery 12-months post-randomization. Secondary outcomes include change in gastrointestinal symptoms, diet adherence, quality of life (including anxiety and depression), eating behaviors, intraepithelial lymphocyte counts on histology, and celiac disease serology, all assessed at baseline and again at 12-months post-randomization. If the primary endpoint of this proposed U01 is met, the 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.

Conditions

Celiac Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Standard of Care

Participants will be provided with continuous Telehealth dietitian follow-up

Group Type: ACTIVE_COMPARATOR

Continuous telemedicine monitoring

Intervention Type: BEHAVIORAL

Regular follow-up with an expert dietitian

Standard of Care Plus Technology

In addition to standard of care, participants will be provided with gluten detection technology so as to assist in navigating the gluten-free diet.

Group Type: EXPERIMENTAL

Gluten detection technology

Intervention Type: BEHAVIORAL

Portable technology to sense gluten after ingestion

Continuous telemedicine monitoring

Intervention Type: BEHAVIORAL

Regular follow-up with an expert dietitian

Interventions

Gluten detection technology

Portable technology to sense gluten after ingestion

Intervention Type: BEHAVIORAL

Continuous telemedicine monitoring

Regular follow-up with an expert dietitian

Intervention Type: BEHAVIORAL

Other Intervention Names

Gluten Detect

Eligibility 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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: collaborator

Columbia University

OTHER

Sponsor Role: lead

Responsible Party

Benjamin Lebwohl

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Benjamin Lebwohl, MD, MS

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Locations

University of Chicago Medical Center

Chicago, Illinois, United States

Site Status: RECRUITING

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Site Status: RECRUITING

Columbia University Irving Medical Center

New York, New York, United States

Site Status: RECRUITING

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Benjamin Lebwohl, MD, MS

Role: CONTACT

BL114@cumc.columbia.edu

212-305-9338

Randi Wolf, PhD, MPH

Role: CONTACT

212-678-3912

Facility Contacts

Sonia Kupfer, MD

Role: primary

773-834-1438

Jocelyn Silvester, MD, PhD

Role: primary

Dawn Adams, MD

Role: primary

615-936-0192

Other Identifiers

U01DK136523

Identifier Type: NIH

Identifier Source: secondary_id

View Link

AAAU4644

Identifier Type: -

Identifier Source: org_study_id