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 @ 3:02 PM
Ignite Modification Date:
2025-12-24 @ 3:02 PM
NCT ID:
NCT06158659
Eligibility Criteria:
Inclusion Criteria:
* Newborn baby, study entry before weaning (within 28 days of birth)
* Exclusively formula fed for at least 3 days prior to study entry and plan to be exclusively formula fed during the study (formula groups) OR plan to be exclusively fed with human milk during the study (breastfeeding group).
* Gestational age of 37-42 weeks (36 weeks and six days is considered 36 weeks gestational age).
* Birth weight of 2500g (5 lbs. 8 oz.) to 4200g (9 lbs. 4 oz.).
* Signed informed consent obtained for infant's participation in the study.
* Parent or guardian of the infant agrees to not enroll the infant in another interventional clinical research study while participating in this study.
Exclusion Criteria:
* History of underlying metabolic or chronic disease; congenital malformation; or any other condition which, in the opinion of the Investigator, is likely to interfere with: the ability of the infant to ingest food, the normal growth and development of the infant, or the evaluation of the infant.
* Evidence of feeding difficulties or formula intolerance, such as vomiting or poor intake, at time of randomization (at investigator discretion).
* Evidence of growth problems or concern for growth.
* Infant was born large for gestational age (LGA) (defined as birth weight-for-age exceeding 90th percentile as plotted on the growth chart provided by Feihe) from mother who was diabetic at childbirth.
* Participant is immunocompromised (according to a doctor's diagnosis of immunodeficiency such as Combined Immunodeficiencies, DiGeorge Syndrome, Wiskott-Aldrich Syndrome, Severe Congenital Neutropenia and Secondary Immunodeficiencies linked to HIV infection, Down Syndrome or others) and children with known head/brain disease/injury.
* Use of probiotics/prebiotics before the study.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
1 Day
Maximum Age:
28 Days
Study:
NCT06158659
Study Brief:
Protocol Section:
NCT06158659