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

Completed · Not applicable

Conditions studied: Growth

In brief

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.

Key facts

Study ID

NCT04957992

Run by

Abbott Nutrition

People needed

607

Starts

2021-07-21

Expected to finish

2025-05-12

Last updated by the study team

2025-06-27

Who can join

Age: any, up to 0. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• MedPharmics, LLC 3192 — Phoenix, Arizona, United States
• HealthStar Research — Glenwood, Arkansas, United States
• HealthStar Research, LLC — Hot Springs, Arkansas, United States
• The Children's Clinic of Jonesboro, P.A. — Jonesboro, Arkansas, United States
• Applied Research Center of Arkansas — Little Rock, Arkansas, United States
• Optumcare Colorado Springs, LLC — Colorado Springs, Colorado, United States
• Boeson Research 3266 — Grand Junction, Colorado, United States
• TOPAZ Clinical Research, Inc. — Apopka, Florida, United States
• Columbus Clinical Services, LLC. — Miami, Florida, United States
• Emerald Coast OBGYN Clinical Research — Panama City, Florida, United States
• ASCLEPES Research Centers — Spring Hill, Florida, United States
• Jedidiah Clinical Research — Tampa, Florida, United States
• Meridian Clinical Research 3259 — Macon, Georgia, United States
• Clinical Research Prime — Idaho Falls, Idaho, United States
• Leavitt Clinical Research — Idaho Falls, Idaho, United States
• Qualmedica Research — Evansville, Indiana, United States
• Deaconess Clinic, Inc. — Evansville, Indiana, United States
• Qualmedica Research, LLC — Owensboro, Kentucky, United States
• Pennington Biomedical Research Center — Baton Rouge, Louisiana, United States
• MedPharmics, LLC 3343 — Covington, Louisiana, United States
• MedPharmics Research 3369 — Slidell, Louisiana, United States
• Boeson Research 3367 — Great Falls, Montana, United States
• Boeson Research 3265 — Kalispell, Montana, United States
• Boeson Research 3267 — Missoula, Montana, United States
• Meridian Clinical Research 3264 — Grand Island, Nebraska, United States

Full record on ClinicalTrials.gov

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