Status:
COMPLETED
Immunosafe-CeD: Are Partially Hydrolysed Gluten Harmful to Celiac Disease Patients?
Lead Sponsor:
Oslo University Hospital
Conditions:
Celiac Disease
Food Intolerance
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 ba...
Detailed Description
Celiac disease (CeD) is a common food-induced inflammatory disease of the small intestine caused by the ingestion of gluten from wheat, barley and rye. It is one of the most prevalent food hypersensit...
Eligibility Criteria
Inclusion
- BMI between 18 and 30 kg/m2
- Biopsy verified celiac disease
- Pos gene test for HLA-DQ2.5 or DQ8
- Strict glutenfree diet for at least 24 months
- Clinical remission
- Sensitive to gluten by accidental intake
- Effective contraception if female in fertile age
Exclusion
- Positive serology at screening
- Pregnant or lactating
- Other disease like Type 1 diabetes, cardiovascular disease, cancer, inflammatory bowel disease, thyroid or kidney disease
- On immunosuppressive drugs
- Smoking
- Food allergy including wheat allergy
- Acute infection
Key Trial Info
Start Date :
January 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2025
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT06151782
Start Date
January 1 2024
End Date
June 1 2025
Last Update
June 29 2025
Active Locations (2)
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1
Clinical Center for Celiac Disease and Autoimmunity
Mainz, Germany, Germany, 55131
2
Dept of Gastroenterology
Oslo, Oslo County, Norway, 0881