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 @ 2:20 PM
Ignite Modification Date:
2025-12-24 @ 2:20 PM
NCT ID:
NCT04655495
Eligibility Criteria:
Inclusion Criteria:
* patients on a proper gluten-free diet (assessing adherence to the gluten-free diet using the Celiac Dietary Adherence Test (CDAT)
* celiac subjects diagnosed through a positive serological test of anti-endomysium antibodies (EMA) and tissue transglutaminase antibodies (TTG) evaluated through a histological abnormality in duodenal biopsies in accordance with Marsh's modified classification
* refractory celiac disease (CD)
Exclusion Criteria:
* Women who are pregnant or breastfeeding
* Subjects who follow special diets: vegetarianism, veganism
* Subjects with psychiatric disorders, diabetes mellitus, autoimmune systemic diseases, previous anaphylactic episodes, systemic disorders
* individual intolerance to disaccharides evaluated through the expired hydrogen test (lactose and fructose)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT04655495
Study Brief:
Protocol Section:
NCT04655495