Gluten Challenge in Celiac Disease - Which Formulation of Gluten Gives the Best Response? (NCT07039773) | Clinical Trial Compass
RecruitingNot Applicable
Gluten Challenge in Celiac Disease - Which Formulation of Gluten Gives the Best Response?
Norway30 participantsStarted 2025-08-01
Plain-language 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.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Comparison of serum IL-2 response rates between the gluten shake group and the cookie group