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:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2025-12-25 @ 2:16 AM
NCT ID:
NCT03857360
Eligibility Criteria:
Inclusion Criteria:
* Children / adolescents aged between 2 and 16 recruited at the time of diagnosis of celiac disease.
The diagnosis of celiac disease will be performed according to the ESPGHAN 2012 Guidelines.
Exclusion Criteria:
* Patients with autoimmune comorbidity (eg type 1 diabetes) or other associated chronic diseases
* Associated serum IgA selective deficiency
* Poor adherence to gluten free diet at the 6-month control, measured by a score\> 10 at the Wessels questionnaire.
* Adherence to the intervention protocol \<85%.
* Antibiotic therapy performed during the 7 days preceding T0 and / or T6.
* Antibiotic therapy during the 3 months of probiotic / placebo treatment.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
2 Years
Maximum Age:
16 Years
Study:
NCT03857360
Study Brief:
Protocol Section:
NCT03857360