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 @ 1:18 PM
Ignite Modification Date:
2025-12-24 @ 1:18 PM
NCT ID:
NCT05172895
Eligibility Criteria:
Inclusion Criteria:
CD will be diagnosed according to the current guidelines. In details, the following standard criteria will be adopted to diagnose CD ("4 out of 5" rule):
* gluten/wheat-dependent symptoms, both intestinal and extraintestinal
* positivity of anti-deamidated gluten peptides (DPG) IgA and IgG antibodies, anti-transglutainase (tTG) IgA and IgG antibodies, and endomysium antibodies (EMA)
* presence of crypt hyperplasia and duodenal villous atrophy on duodenal biopsy
* presence of HLA haplotypes DQ2 and/or DQ8
* resolution of symptoms with a rigorous GFD
Additional inclusion criteria, both for the retrospective and prospective part of the study, will be:
* age \>18 and \<65 years
* complete clinical records
* clinical and laboratory follow-up of at least one year from diagnosis -
Exclusion Criteria:
* age \<18 and \>65 years
* incomplete medical records
* lack of clinical and laboratory follow-up of at least one year from diagnosis
* pregnancy
* alcohol and/or drug abuse
* diagnosis of IBD or other gastrointestinal organic disease
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT05172895
Study Brief:
Protocol Section:
NCT05172895