K90.0
Conditions
Interventions
Group 1: Randomized, crossover design with 5 test periods and 20 different administration sequences. Each participant receives 4 single provocations and one placebo at intervals of 1-2 (maximum 4) wee
Sponsors
Universitätsmedizin der Johannes Gutenberg Universität Mainz
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: - BMI 17-30 kg/m2 - Willingness to participate in the study and signing of the written informed consent form - Diagnosis of celiac disease according to established guidelines based on positive serology (endomysium test, IgA (in case of IgA deficiency igG) anti-TG2 and/or IgG-DGP) and/or duodenal endoscopy with biopsies showing villous atrophy with Marsh grade >2 according to European guidelines - Strict adherence to a gluten-free diet in the last 12 months - Current remission of clinical symptoms
Exclusion criteria
Exclusion criteria: - Positive serology (IgA anti-TG2) above the upper normal range) at the screening visit - Existing pregnancy - Patients with other active inflammatory diseases such as uncontrolled hypo- or hyperthyroidism, type 1 diabetes, cardiovascular disease, kidney disease, inflammatory bowel disease or severe food allergies - Long-term medication with immunosuppressants/corticosteroids - Severe acute infection
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparison of the immune response to identical amounts (1 g) of wheat gluten vs. barley gluten vs. low-dose barley gluten (0.05 g unfermented or fermented) based on the serum IL-2 increase four hours after vs. before oral challenge | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluation of any gastrointestinal symptoms that occurred after each challenge using the celiac disease-specific GSRS-CeD symptom score. Presence of gluten-immunogenic peptides in the 4-hour urine after vs. before provocation using the G12 antibody test. Exploratory measurement of new serum parameters of inflammatory celiac disease activity developed by us | — |
Countries
Germany, Norway
Contacts
Public ContactDetlef Schuppan
Universitätsmedizin der Johannes Gutenberg Universität Mainz
Outcome results
None listed