Celiac Disease
Conditions
Keywords
Gluten challenge, Interleukin-2, Shake, Cookie, T cells, Whole blood cytokine release assay, GI Symptoms
Brief 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.
Interventions
DIETARY_SUPPLEMENTVital wheat gluten
Gluten-containing shake vs gluten-containing cookie
Sponsors
Oslo University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* Positive serology (IgA-TG2 below upper level of normal) at screening visit * Pregnancy or breast feeding. Fertile women must use effective contraception. * Other inflammatory disease like uncontrolled hypothyreosis, type 1 diabetes, cardiovascular diseases, thyroid and renal disorders, inflammatory bowel diseases or any other disease that in the opinion of the responsible clinician makes the patient unsuitable for the study * Using of immunosuppressive/steroid medications * Wheat allergy * Severe acute infection
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of serum IL-2 response rates between the gluten shake group and the cookie group | From baseline to 4 hours at visit 1 | A responder is defined as an individual exhibiting a log-transformed cytokine level equal to or greater than 0. This level corresponds to 1.0 pg/ml in concentration of IL-2 in serum. The hypothesis is that there is a higher proportion of responders in the gluten shake group compared to the cookie group. |
Secondary
| Measure | Time frame |
|---|---|
| Correlation between serum IL-2 response levels and baseline whole blood plasma IL-2 | From baseline to 6 hours after gluten intake |
| Correlation between serum IL-2 response levels and baseline number of gluten-specific T cells | From baseline to 6 hours after gluten intake |
| Correlation between serum IL-2 response levels and symptom severity | From baseline to 6 hours after gluten intake |
| Comparison of serum IL-2 response levels and serum gluten peptide levels | From baseline to 6 hours after gluten intake |
Countries
Norway
Outcome results
None listed