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 @ 11:29 PM
Ignite Modification Date:
2025-12-24 @ 11:29 PM
NCT ID:
NCT04277156
Eligibility Criteria:
Inclusion criteria:
1. age younger than 18 years;
2. oral or intravenous antibiotic therapy which started within 24 hours of enrolment;
3. signed informed consent.
Exclusion criteria:
1. pre-existing acute or chronic diarrhea, history of chronic gastrointestinal disease (e.g. inflammatory bowel disease, cystic fibrosis, coeliac disease, food allergy) or other severe chronic diseases (eg, neoplastic diseases),
2. major medical problems (eg. immunocompromised, major developmental or genetic abnormality);
3. taking any of the study products (or probiotic strains included in the study products) at the time of study commencement;
4. use of antibiotics within 4 weeks prior to enrolment,
5. prematurity;
6. exclusive breastfeeding.
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT04277156
Study Brief:
Protocol Section:
NCT04277156