BIG Study (Brain, Immune, and Gut Health Evaluation of Infants/Young Children Fed Infant Formula,… (NCT04957992) | Clinical Trial Compass
CompletedNot Applicable
BIG Study (Brain, Immune, and Gut Health Evaluation of Infants/Young Children Fed Infant Formula, and Later Supplemental Toddler Nutrition, With 5 Specific HMOs)
United States607 participantsStarted 2021-07-21
Plain-language summary
The purpose of this study is to evaluate the growth and development outcomes of infants fed a new infant formula and toddler drink through 24 months of age.
Who can participate
Age range0 Days – 14 Days
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Participant is judged to be in good health as determined from participant's medical history
* Participant is a singleton from a full-term birth with a gestational age of 37 - 42 weeks by parent report
* Participant's birth weight was ≥ 2490 g (\~5 lbs. 8 oz.)
* Parent(s) confirm their intention to feed their infant the study product as the sole source of feeding from Study Visit 1 to 6 months of age, and as the sole milk beverage during the first 12 months of life
* Parent(s) confirm their intention to feed the infant the assigned toddler drink from 12 months of life to 24 months of life as the primary milk beverage
* Parent(s) confirm their intention not to administer vitamin or mineral supplements,(except for vitamin D supplements if instructed by their healthcare professional) from enrollment through the duration of the study
* Parent(s) confirm their intention not to administer solid foods or juices to the infant from enrollment through 6 months of age unless recommended by the participant's HCP
* Participant's parent(s) has voluntarily signed and dated an informed consent form (ICF), approved by an Institutional Review Board/Independent Ethics Committee (IRB/IEC) and provided Health Insurance Portability and Accountability Act (HIPAA) (or other applicable privacy regulation) authorization prior to any participation in the study
* If parent(s) elect to feed the participant human milk, they confirm that their infant was fed human milk since birth and…