RecruitingNot ApplicableNCT07039773

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


Sponsor

Oslo University Hospital

Enrollment

30 participants

Start Date

Aug 1, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Vital wheat gluten and Vital wheat gluten for people with celiac disease. The study is currently recruiting participants at 2 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIETARY_SUPPLEMENTVital wheat gluten

Gluten-containing shake vs gluten-containing cookie

DIETARY_SUPPLEMENTVital 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, Norway

Lovisenberg Diakonale Hospital

Oslo, Oslo, Norway

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NCT07039773


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