Immune Responses to Gluten

Part of paid clinical trials in Aurora, Colorado.

Sponsor
Boston Children's Hospital
Study ID
NCT05209568
Status
Recruiting
Apply to this trial

Conditions

  • Celiac Disease
  • Celiac Disease in Children
  • Digestive System Disease
  • Gastrointestinal Diseases
  • Gluten Sensitivity
  • Intestinal Disease
  • Malabsorption Syndromes

Eligibility Criteria

Sex
ALL
Age
2 Years - 101 Years
Healthy Volunteers
Accepted

Interventions

  • Gluten Powder — DIETARY_SUPPLEMENT
    Single oral dose of gluten powder

Study Details

This is a study of immune responses after eating gluten powder in people with celiac disease and healthy controls.

Key Dates

Start date
Jan 15, 2023
Status verified
Apr 2025
Primary completion
Sep 30, 2028
Completion
Sep 30, 2029

Study Design

Enrollment
400 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: Celiac Disease
    Individuals with a confirmed diagnosis of celiac disease based on serology and/or histology
  • Experimental: Healthy Controls
    Individuals without a diagnosis of celiac disease

Primary Outcome Measure

Change in serum interleukin-2 (IL-2) level from baseline to 4 hours after a single oral dose of gluten [ Time Frame: Baseline, 4 hours ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Children's Hospital ColoradoAuroraColorado80045
Marisa Stahl, MD, MSCS
[email protected]
720-777-2484
Boston Children's HospitalBostonMassachusetts02115
Jocelyn A Silvester, MD, PhD
[email protected]
617-355-8880

Find similar trials in Aurora, CO

By condition
Celiac disease
By specialty
GastroenterologyAutoimmune disease
By research site
Children's Hospital Colorado· Aurora, COBoston Children's Hospital· Boston, MA

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