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 @ 5:00 PM
Ignite Modification Date:
2025-12-24 @ 5:00 PM
NCT ID:
NCT05508750
Eligibility Criteria:
Inclusion Criteria:
* Normal term infant (37-42 weeks gestation at birth)
* Infant \<15 (+3) days of age at first study feeding, Birth constitutes day 0
* Infant birth weight of ≥2500 g (5.5 lbs.)
* Healthy Infant
* Caregiver who has previously decided to exclusively feed infant formula or exclusively breastfeed and is willing to continue with current feeding method throughout the study (breastfeeding or formula feeding)
* Caregiver willing to conform to protocol requirements (e.g. measuring, feeding, completion of food intake and tolerance diaries, and reporting of AEs)
* Caregiver willing and able to sign informed consent
Exclusion Criteria:
* Infant born in multiple birth (i.e., twins, triplets, etc.)
* Infant born with medical complications (e.g., neurological, cerebral palsy, etc.)
* Infant with family history (parents or siblings) of confirmed Milk or Soy allergies
* Infant with failure to thrive, fever, any GI tract abnormalities (e.g., short gut, gastroesophageal reflux, etc.), any congenital illness or malformation that may affect infant feeding or normal growth
* Caregiver intent to feed non-study formula or solid food during the study
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
0 Days
Maximum Age:
14 Days
Study:
NCT05508750
Study Brief:
Protocol Section:
NCT05508750