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Assessing Immune Responses to Gluten: A Comparative Study of Liquid Versus Solid Gluten Administration
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.
Age
18 - 80 years
Sex
ALL
Healthy Volunteers
No
Oslo University Hospital
Oslo, Oslo County, Norway
Lovisenberg Diakonale Hospital
Oslo, Oslo County, Norway
Start Date
August 1, 2025
Primary Completion Date
May 1, 2026
Completion Date
December 1, 2026
Last Updated
June 26, 2025
30
ESTIMATED participants
Vital wheat gluten
DIETARY_SUPPLEMENT
Vital wheat gluten
DIETARY_SUPPLEMENT
Lead Sponsor
Oslo University Hospital
Collaborators
NCT07239336
NCT06356220
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT07069127