Gluten Challenge in Celiac Disease - Which Formulation of Gluten Gives the Best Response?

Sponsor
Oslo University Hospital
Study ID
NCT07039773
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Vital wheat gluten — DIETARY_SUPPLEMENT
    Gluten-containing shake vs gluten-containing cookie
  • Vital wheat gluten — DIETARY_SUPPLEMENT
    Half of participants will receive gluten-containing shake first, then gluten-containing cookie next, and vice versa

Study Details

The goal of this clinical trial is to evaluate the immune response to gluten in patients with celiac disease (CeD) by comparing different forms of gluten administration. The participant population includes adults diagnosed with CeD, who are adhering to a gluten-free diet (GFD). The main questions it aims to answer are: * Does liquid gluten administration elicit a higher IL-2 cytokine response compared to solid gluten administration? * What is the relationship between serum IL-2 levels and gluten peptide serum concentrations following gluten challenges? Researchers will compare the responses of two groups: participants receiving liquid gluten (shake) to those receiving solid gluten (cookie) to determine if there is a significant difference in the IL-2 response rates between the two forms. Participants will be asked to: * Undergo two gluten challenges (liquid and solid) in a randomized order with at least 4 weeks apart. * Provide blood samples before and after each challenge to measure serum IL-2 levels and gluten peptide concentrations over a period of 6 hours. * Report any symptoms experienced following each gluten challenge.

Key Dates

Start date
Aug 1, 2025
Status verified
Apr 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE

Arms

  • Active Comparator: Gluten shake
    Liquid form
  • Active Comparator: Gluten cookie
    Solid form

Primary Outcome Measure

Comparison of serum IL-2 response rates between the gluten shake group and the cookie group [ Time Frame: From baseline to 4 hours at visit 1 ]

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