Recruiting

Gluten Technology

Sponsor:

Columbia University

Code:

NCT06059716

Conditions

Celiac Disease

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Gluten detection technology

Continuous telemedicine monitoring

Study Details

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.

Conditions

Celiac Disease

Study ID

NCT06059716

Start date

Oct 8, 2024

Status verified date

Jun, 2026

Completion date

Aug 31, 2028

Anticipated

Primary completion date

Aug 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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).

Study Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Standard of Care

Participants will be provided with continuous Telehealth dietitian follow-up

experimental: 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.

Interventions

Gluten detection technology

Portable technology to sense gluten after ingestion

Continuous telemedicine monitoring

Regular follow-up with an expert dietitian

Primary outcome measure

  • Small Intestinal Healing [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Benjamin Lebwohl, MD, MS

212-305-9338BL114@cumc.columbia.edu

Randi Wolf, PhD, MPH

212-678-3912

Locations

University of Chicago Medical Center

Recruiting

Chicago, Illinois, United States, 60637

Contacts

Sonia Kupfer, MD

773-834-1438

Beth Israel Deaconess Medical Center

Recruiting

Boston, Massachusetts, United States, 02215

Columbia University Irving Medical Center

Recruiting

New York, New York, United States, 10032

Vanderbilt University Medical Center

Recruiting

Nashville, Tennessee, United States, 37232

Contacts

Dawn Adams, MD

615-936-0192

More Information

Sponsor

Columbia University

Last update posted

Jun 10, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Columbia University on 2026-06-10.