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 range
0 Days – 14 Days
Sex
ALL
See this in plain English?
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This study was focused on growth as the primary outcome in infants and young children — can you help me understand what specific aspects of my child's growth would be most relevant to discuss in light of what this trial was measuring?
2The trial tested formula with 5 specific human milk oligosaccharides (HMOs) along with toddler nutrition — are there currently any commercially available formulas with a similar HMO profile that you'd consider appropriate for my child, based on what this research found?
3Since this study is now completed, has the data been published or shared anywhere, and can you help me understand whether the results suggest any meaningful difference in growth outcomes compared to standard formula?
4This trial was categorized as Phase NA, meaning it wasn't testing a drug in the traditional sense — does that change how you'd interpret the safety and reliability of the findings compared to a standard pharmaceutical trial?
5Given that this study looked at brain, immune, and gut health alongside growth, are there any of those secondary areas where you think the findings might be worth considering when choosing a formula or toddler nutrition plan for my child?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.