NCT07039773

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

Assessing Immune Responses to Gluten: A Comparative Study of Liquid Versus Solid Gluten Administration

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Oslo University Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Celiac Disease

Interventions

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

Timeline

• Start date: 2025-08-01
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2025-06-26
• Last updated: 2026-04-17

Locations

2 sites across 1 country: Norway