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 @ 7:09 PM
Ignite Modification Date:
2025-12-24 @ 7:09 PM
NCT ID:
NCT02031003
Eligibility Criteria:
Inclusion Criteria:
* Healthy, term (no less than 37 weeks and no greater than 42 weeks) singleton infants; between 25 days to 45 days post natal age (date of birth = Day 0) and weight for age ≥3rd and ≤97th percentiles according to Taiwan growth charts at the time of study entry.
* Human milk fed infants were exclusively consuming and tolerating HM and the mother must have made the decision to continue to exclusively breastfeed.
* Formula-fed infants were exclusively consuming and tolerating a cow's milk infant formula and parents/LAR must have previously made the decision to continue to exclusively formula feed.
Exclusion Criteria:
* Infants receiving any amount of supplemental HM with infant formula feeding or vice versa
* Family history of siblings with documented cow's milk protein intolerance/allergy
* Major congenital malformations, suspected or documented systemic or congenital infections, evidence systemic diseases
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
25 Days
Maximum Age:
45 Days
Study:
NCT02031003
Study Brief:
Protocol Section:
NCT02031003