Gluten Technology and Education for Celiac Health

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Columbia University
Study ID
NCT06059716
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Gluten detection technology — BEHAVIORAL
    Portable technology to sense gluten after ingestion
  • Continuous telemedicine monitoring — BEHAVIORAL
    Regular follow-up with an expert dietitian

Study Details

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.

Key Dates

Start date
Oct 8, 2024
Status verified
Jun 2026
Primary completion
Aug 31, 2027
Completion
Aug 31, 2028

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

Small Intestinal Healing [ Time Frame: 12 months ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
University of Chicago Medical CenterChicagoIllinois60637
Sonia Kupfer, MD
773-834-1438
Beth Israel Deaconess Medical CenterBostonMassachusetts02215
Jocelyn Silvester, MD, PhD
Columbia University Irving Medical CenterNew YorkNew York10032-
Vanderbilt University Medical CenterNashvilleTennessee37232
Dawn Adams, MD
615-936-0192

Find similar trials in Chicago, IL

By condition
Celiac disease
By specialty
GastroenterologyAutoimmune disease
By research site
University of Chicago Medical Center· Chicago, ILBeth Israel Deaconess Medical Center· Boston, MAColumbia University Irving Medical Center· New York, NYVanderbilt University Medical Center· Nashville, TN

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