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 @ 2:54 PM
Ignite Modification Date:
2025-12-24 @ 2:54 PM
NCT ID:
NCT04441359
Eligibility Criteria:
Inclusion Criteria:
* Healthy babies born between 37 - 42 weeks of gestation and with weight appropriate for gestational age (between percentiles 3 and 97)
* Healthy babies aged between 0 - 4 months of age
* Babies exclusively fed with an infant formula on enrolment into the study
Exclusion Criteria:
* The presence of an infection at the moment of the recruitment or 1 week before recruitment
* The presence of important pathologies (intestinal, cardiopathy, mental retardation, etc.)
* Any other diseases related to the immune system (primary immunodeficiency)
* Parents not able to comply with the study follow up (according to physician criteria)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
1 Day
Maximum Age:
4 Months
Study:
NCT04441359
Study Brief:
Protocol Section:
NCT04441359