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Gluten Challenge in Celiac Disease - Which Formulation of Gluten Gives the Best Response?
Led by Oslo University Hospital · Updated on 2026-04-17
30
Participants Needed
2
Research Sites
69 weeks
Total Duration
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AI-Summary
What this Trial Is About
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
Official Title
Gluten Challenge in Celiac Disease - Which Formulation of Gluten Gives the Best Response?
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Body mass index between 18 and 33 kg/m2
- Willingness to follow study procedures and sign informed consent
- Previous diagnosis of celiac disease based on positive blood tests and duodenal biopsy showing villous atrophy
- Strict adherence to a gluten-free diet for at least the last 12 months
You will not qualify if you...
- Positive serology (IgA-TG2 above normal limit) at screening
- Pregnancy or breastfeeding; fertile women must use effective contraception
- Other inflammatory diseases such as uncontrolled hypothyreosis, type 1 diabetes, cardiovascular disease, thyroid or kidney disorders, or inflammatory bowel disease
- Use of immunosuppressive or steroid medications
- Wheat allergy
- Severe acute infection
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Oslo University Hospital
Oslo, Oslo, Norway, 0372
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2
Lovisenberg Diakonale Hospital
Oslo, Oslo, Norway, 0456
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How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
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