Celiac Disease Clinical Trial
Official title:
Towards Comprehensive Analytical Methods for Partially Hydrolysed Gluten to Assess Product Safety for Celiac Disease Patients
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. This will be done by four one-day challenges with intervals around four weeks.
Status | Recruiting |
Enrollment | 25 |
Est. completion date | December 31, 2026 |
Est. primary completion date | December 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 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 Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Germany | Clinical Center for Celiac Disease and Autoimmunity | Mainz | |
Norway | Dept of Gastroenterology | Oslo |
Lead Sponsor | Collaborator |
---|---|
Oslo University Hospital |
Germany, Norway,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Interleukin-2 in serum | Cytokine measurement by MSD Mesoscale | 4 hours after intake | |
Secondary | GIP in urine 4 hours after challenge and feces 2 days after challenge | Detection of gluten by test kits for BioMedal | Four hours after challenge (urine) and 2 days after challenge (feces) |
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