Does a gluten shake or a gluten cookie produce a stronger immune response in celiac disease?
Assessing Immune Responses to Gluten: A Comparative Study of Liquid Versus Solid Gluten Administration
NA · Oslo University Hospital · NCT07039773
This trial tests whether a liquid gluten shake or a solid gluten cookie causes a bigger IL-2 immune response in adults with celiac disease who have been on a gluten-free diet.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Oslo University Hospital (other) |
| Locations | 2 sites (Oslo, Oslo and 1 other locations) |
| Trial ID | NCT07039773 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults with a prior biopsy-confirmed diagnosis of celiac disease who have adhered to a strict gluten-free diet for at least 12 months, have BMI 18–33 kg/m2, and meet the study screening labs and safety criteria are ideal candidates.
Not a fit: People with ongoing positive celiac serology, active inflammatory or systemic illnesses, pregnant or breastfeeding women, children, or those unable to attend the Oslo clinic visits are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the results could help standardize gluten-challenge methods and improve detection of immune responses in celiac disease, which may speed research and improve monitoring.
How similar studies have performed: Previous gluten challenge studies have shown rapid, measurable IL-2 rises after gluten exposure, so this work builds on existing findings but specifically compares liquid versus solid formulations.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Oslo, Oslo and 1 other locations
- Oslo University Hospital — Oslo, Oslo, Norway (RECRUITING)
- Lovisenberg Diakonale Hospital — Oslo, Oslo, Norway (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Celiac Disease, Gluten challenge, Interleukin-2, Shake, Cookie, T cells, Whole blood cytokine release assay, GI Symptoms