Gluten Challenge in Celiac Disease - Which Formulation of Gluten Gives the Best Response?

Launched by OSLO UNIVERSITY HOSPITAL · Jun 18, 2025

Keywords

ClinConnect Summary

This clinical trial is studying how different forms of gluten affect the immune system in adults with celiac disease who have been following a strict gluten-free diet for at least a year. Specifically, researchers want to know if drinking gluten as a liquid causes a stronger immune response compared to eating gluten in solid form, like a cookie. They will also look at how certain proteins related to gluten show up in the blood after these gluten “challenges.”

Adults diagnosed with celiac disease since childhood, who have a body weight within a healthy range and have been strictly avoiding gluten, may be eligible to join. Participants will take part in two test days, at least four weeks apart, where they will consume gluten in either liquid or solid form in a random order. Blood samples will be taken before and for six hours after each gluten intake to measure immune activity and gluten levels. Participants will also be asked to share any symptoms they experience during the test. The study is not yet recruiting, and people with certain health conditions, pregnancy, or wheat allergy will not be able to participate. This trial aims to better understand how gluten affects the body in celiac disease, which could help improve future testing and treatments.

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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