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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• BMI 18-33 kg/m2

• Willingness to comply with the study procedure and having signed informed, written consent

• Previous diagnosis of coeliac disease according to established guidelines based on positive serology (Endomysium test, IgA-TG2 and/or IgG-DGP) (diagnosed in childhood) and a duodenal biopsy showing villous atrophy graded as Marsh 3 according to guidelines from European Society for Study of Coeliac Disease .

• Strict adherence to a gluten-free diet at least the 12 last months.

Locations
Other Locations
Norway
Lovisenberg Diakonale Hospital
RECRUITING
Oslo
Oslo University Hospital
RECRUITING
Oslo
Time Frame
Start Date: 2025-08-01
Estimated Completion Date: 2026-12
Participants
Target number of participants: 30
Treatments
Active_comparator: Gluten shake
Liquid form
Active_comparator: Gluten cookie
Solid form
Related Therapeutic Areas
Sponsors
Leads: Oslo University Hospital

This content was sourced from clinicaltrials.gov

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