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NOT YET RECRUITING
NCT07039773
NA

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

Sponsor: Oslo University Hospital

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2025-08-01

Completion Date

2026-12

Last Updated

2025-06-26

Healthy Volunteers

No

Conditions

Interventions

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

Locations (2)

Oslo University Hospital

Oslo, Oslo County, Norway

Lovisenberg Diakonale Hospital

Oslo, Oslo County, Norway