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Immunosafe-CeD: Are Partially Hydrolysed Gluten Harmful to Celiac Disease Patients?
Sponsor: Oslo University Hospital
Summary
The study will compare the immune response in CeD patients to wheat and barley gluten at high doses (1 gram), and also investigate the reponses to low dose barley gluten and also hydrolyzed, malted barley and placebo. This will be done by five one-day challenges with intervals around four weeks.
Official title: Towards Comprehensive Analytical Methods for Partially Hydrolysed Gluten to Assess Product Safety for Celiac Disease Patients
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
33
Start Date
2024-01-01
Completion Date
2025-06-01
Last Updated
2026-04-24
Healthy Volunteers
No
Conditions
Interventions
Wheat gluten 1000 mg
Nothing to add here
Barley gluten 1000 mg
Nothing to add here
Barley gluten 50 mg
Nothing to add here
Barley hydrolyzed gluten 50 mg
Nothing to add here
Placebo slurry
In slurry, measurement of immune activation (Interleukin-2) four hours after intake
Locations (2)
Clinical Center for Celiac Disease and Autoimmunity
Mainz, Germany, Germany
Dept of Gastroenterology
Oslo, Oslo, Norway