Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:50 PM
Ignite Modification Date:
2025-12-24 @ 11:50 PM
NCT ID:
NCT00620451
Eligibility Criteria:
Inclusion Criteria:
* Male and female adults with celiac disease (as demonstrated by duodenal/jejunal biopsy or by capsule endoscopy plus positive anti-tTG)
* Marsh score ≥ II at screening
* Positive serum anti-tTG antibodies as determined by screening serology
* Willing to comply with a gluten-free diet for the duration of the study
Exclusion Criteria:
* Has refractory Celiac Disease or severe complications of celiac disease (eg, EATL-, ulcerative jejunitis, perforation, etc.)
* Has chronic active GI disease other than Celiac Disease
* Has diabetes (Type 1 or Type 2) or other autoimmune disease that might interfere with the conduct of the study
* Has hemoglobin value below 8.5 g/dL
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT00620451
Study Brief:
Protocol Section:
NCT00620451