Gluten Challenge in Celiac Disease - Which Formulation of Gluten Gives the Best Response?
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Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Source: NCT07039773, who can take part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Oslo University Hospital
- Trial code
- NCT07039773
- Record updated
- 17 April 2026
- Original description
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:Read full original descriptionShow less
Assessing Immune Responses to Gluten: A Comparative Study of Liquid Versus Solid Gluten Administration
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.
Inclusion: 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: Using of immunosuppressive/steroid medications; 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; Wheat allergy; Severe acute infection; Positive serology (IgA-TG2 below upper level of normal) at screening visit; Pregnancy or breast feeding. Fertile women must use effective contraception.