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:
2025-12-26 @ 10:56 AM
Ignite Modification Date:
2025-12-26 @ 10:56 AM
NCT ID:
NCT07242508
Eligibility Criteria:
Inclusion Criteria:
* Healthy, full term, infants with a birth weight between 2500-4500 grams
* Parents independently from study decided to not breastfeed their infant
* Parents agree to feed the assigned study formula as the infant's sole source of nutrition for the duration of the study
* have read and voluntarily signed an informed consent form
* parents are capable of completing study procedures required by the protocol
Exclusion Criteria:
* suffering from any anatomic and/or physiologic condition that would interfere with normal growth, development or feeding
* are required to take medications or supplements known to influence growth and development
* have a maternal history with known adverse effects on the fetus and/or the newborn infant
* have previous or current antibiotics use (antibiotics administered during delivery are permitted)
* have received or are planning to receive probiotics, prebiotics, or nutritional supplements prior to and throughout the trial (excluding vitamin D and vitamin K supplementation)
* personal history of or parents/siblings diagnosed with cow's milk protein allergy or lactose intolerance
* multiple birth
* participation in another trial
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
0 Days
Maximum Age:
3 Days
Study:
NCT07242508
Study Brief:
Protocol Section:
NCT07242508