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 @ 1:21 AM
Ignite Modification Date:
2025-12-25 @ 1:21 AM
NCT ID:
NCT07050693
Eligibility Criteria:
Inclusion Criteria:
* Healthy school-going children aged 12 to 48 months who attend school at least 5 days a week
Exclusion Criteria:
* Age less than 12 months and more than 48 months;
* Concomitant presence of chronic diseases
* Congenital heart disease;
* Tuberculosis;
* Functional gastrointestinal disorders;
* Gastrointestinal or urinary surgery of the respiratory tract;
* Autoimmune diseases;
* Immunodeficiencies;
* Chronic inflammatory bowel diseases;
* Celiac disease;
* Cystic fibrosis;
* Metabolic diseases;
* Lactose intolerance;
* Tumors;
* Chronic lung diseases and malformations of the gastrointestinal tract;
* Food allergies;
* Eosinophilic esophagitis;
* Other hypereosinophilic diseases of the gastrointestinal tract;
* Diarrhea at enrollment;
* Severe malnutrition (z score for weight/height less than 3SD);
* Taking antibiotics and/or pre/pro/symbiotics/immunostimulants within 2 weeks of starting the study;
* Breastfeeding in progress
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Months
Maximum Age:
48 Months
Study:
NCT07050693
Study Brief:
Protocol Section:
NCT07050693