Does a gluten shake or a gluten cookie produce a stronger immune response in celiac disease?

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Adults with biopsy-proven celiac disease who have followed a strict gluten-free diet will undergo two supervised gluten challenges — one with a liquid shake and one with a solid cookie — given in randomized order at least four weeks apart. Blood samples will be collected before and after each challenge to measure serum IL-2 and gluten peptide concentrations over time. The study compares the magnitude and timing of the IL-2 cytokine response between the two formulations to see if one elicits a stronger or faster immune signal. Findings will inform which gluten formulation is most sensitive for provoking measurable immune responses in controlled challenge settings.

Why it matters

Who can join: the full rules

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

Where it's running

• Oslo University Hospital
  Oslo, Oslo, Norway Recruiting
• Lovisenberg Diakonale Hospital
  Oslo, Oslo, Norway Recruiting

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.