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 @ 10:04 PM
Ignite Modification Date:
2025-12-24 @ 10:04 PM
NCT ID:
NCT02118935
Eligibility Criteria:
Inclusion Criteria:
* Singleton, 14-35 days of age at baseline
* Term infant with birth weight of a minimum of 2500 grams
* Solely formula-fed
* Signed Informed Consent and Protected Health Information authorization
Exclusion Criteria:
* History of underlying metabolic or chronic disease, congenital malformation, or immunocompromised
* Feeding difficulties or formula intolerance
* Maternal history of illicit drug use or psychiatric disease
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
14 Days
Maximum Age:
35 Days
Study:
NCT02118935
Study Brief:
Protocol Section:
NCT02118935