CompletedNot Applicable

Immunosafe-CeD: Are Partially Hydrolysed Gluten Harmful to Celiac Disease Patients?

Germany, Norway33 participantsStarted 2024-01-01

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Interleukin-2 in serum

Timeframe: 4 hours after intake

Trial details

NCT IDNCT06151782

SponsorOslo University Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-05-30

View on ClinicalTrials.gov More Celiac Disease trials