Clinical Trial

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

Study acronym: SHAKE
Recruiting
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Summary
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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-06-18.
Status change: Not Yet Recruiting → Recruiting 2026-04-14
Trial Details
NCT Number NCT07039773
Lead Sponsor Oslo University Hospital
Conditions Celiac Disease
Enrollment 30 participants
Start Date 2025-08-01
Primary Completion 2026-12 (estimated)
Study Completion 2026-12 (estimated)
Updated on ClinicalTrials.gov 2026-04-17