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 @ 3:54 AM
Ignite Modification Date:
2025-12-25 @ 3:54 AM
NCT ID:
NCT05484102
Eligibility Criteria:
Inclusion Criteria:
* Healthy children aged 12-48 months
* attending day care or preschool for at least 5 days a week
Exclusion Criteria:
The exclusion criteria were:
* age \<12 months or \>48 months
* concomitant chronic infections, chronic systemic diseases, chronic inflammatory bowel diseases, autoimmune diseases, immunodeficiency, malignancy, metabolic diseases
* chronic respiratory tract diseases including respiratory allergies and cystic fibrosis
* malformations of gastrointestinal or urinary or respiratory tract
* history of respiratory or gastrointestinal or urinary tract surgery
* congenital cardiac defects
* functional bowel disorders
* suspected or challenge-proved food allergy, food intolerances
* severe malnutrition (z-score for weight-for-height \<3 standard deviation scores)
* use of antibiotics or pre/pro/synbiotics or immune stimulating products in the 2 weeks before the enrolment
* Siblings of subjects enrolled in the study were not allowed to participate to the trial.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
12 Months
Maximum Age:
48 Months
Study:
NCT05484102
Study Brief:
Protocol Section:
NCT05484102