NCT07039773 Gluten Challenge in Celiac Disease - Which Formulation of Gluten Gives the Best Response?
| NCT ID | NCT07039773 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Oslo University Hospital |
| Condition | Celiac Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2025-08-01 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 30 participants in total. It began in 2025-08-01 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Frequently Asked Questions
Who can join the NCT07039773 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Celiac Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07039773 currently recruiting?
Yes, NCT07039773 is actively recruiting participants. Visit ClinicalTrials.gov or contact Oslo University Hospital to inquire about joining.
Where is the NCT07039773 trial being conducted?
This trial is being conducted at Oslo, Norway, Oslo, Norway.
Who is sponsoring the NCT07039773 clinical trial?
NCT07039773 is sponsored by Oslo University Hospital. The trial plans to enroll 30 participants.