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 @ 12:45 AM
Ignite Modification Date:
2025-12-25 @ 12:45 AM
NCT ID:
NCT02332967
Eligibility Criteria:
Inclusion Criteria:
* healthy newborn infants
* full term infant (37 - 42 weeks gestation)
* birth weight between 2.5 and 4.5 kg
* singleton birth
* the infant's mother has elected to exclusively formula feed her baby, from enrollment to 4 months of age
* having obtained his7her legal representative's informed consent
Exclusion Criteria:
* congenital illness or malformation that may affect normal growth
* significant pre-natal and/or post-natal disease
* hospitalization in the first 14 days of life after the child has left the maternity ward
* receiving antibiotic treatment at time of enrolment
* newborn whose parents/caregivers cannot be expected to comply with treatment
* newborn currently participating in another interventional clinical trial.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
1 Week
Maximum Age:
4 Months
Study:
NCT02332967
Study Brief:
Protocol Section:
NCT02332967