BIG Study (Brain, Immune, and Gut Health Evaluation of Infants/Young Children Fed Infant Formula, and Later Supplemental Toddler Nutrition, With 5 Specific HMOs)

Launched by ABBOTT NUTRITION · Jul 1, 2021

Keywords

ClinConnect Summary

The Infant Formula and Toddler Drink Feeding Study is designed to see how a new infant formula and toddler drink can help with the growth and development of babies up to 24 months old. The researchers want to understand how these products work when used as the main source of nutrition for infants during their first two years of life. The study is currently active but not recruiting new participants, and it is open to babies aged 0 to 14 months.

To be eligible for this study, babies need to be healthy, born full-term (between 37 and 42 weeks), and have a birth weight of at least 5 pounds 8 ounces. Parents must agree to feed their baby only the study products during specific times: the formula from birth to 6 months and the toddler drink from 12 to 24 months, without giving any solid foods or other supplements unless advised by a healthcare professional. Participants will need to sign consent forms and follow study guidelines closely. This trial aims to provide valuable information about the nutritional needs of growing infants and toddlers.

Gender

ALL

Eligibility criteria

• 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 confirm their intention to exclusively feed human milk as the sole source of feeding through 6 months of age.
• • If parent(s) of human milk fed participant elect to supplement or wean, they confirm their intention to use the experimental supplemental/weaning formula and experimental toddler drink as the primary milk beverage.
• Exclusion Criteria:
• • An adverse maternal, fetal or participant medical history that is thought by the investigator to have potential for effects on tolerance, growth, and/or development
• • Awareness of a positive drug screen (including but not limited to cocaine, heroin, or methamphetamine) in the mother or participant
• • Suspected maternal substance abuse including alcohol
• • Participant is taking and plans to continue medications (including over the counter (OTC), such as Mylicon® for gas), home remedies (such as juice for constipation), herbal preparations, prebiotics or probiotics, or rehydration fluids that might affect GI tolerance
• • Participant is in another study that has not been approved as a concomitant study by AN
• • Participant has been treated with antibiotics (except for topical antibiotics, eye drops) prior to enrollment
• • Participant has been treated with other medications (besides antibiotics) that in the opinion of the PI may affect growth, GI tolerance and/or development, prior to enrollment