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

Not Applicable

Completed

• Conditions: Growth

• Registration Number: NCT04957992
• Lead Sponsor: Abbott Nutrition

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-07-01
• Study First Submitted QC: 2021-07-01
• Study First Posted: 2021-07-12
• Study Start: 2021-07-21
• Primary Completion: 2025-05-12
• Study Completion: 2025-05-12
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-24
• Last Update Posted: 2025-06-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 607

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Growth	Study Day 1 to 6 Months of Age	weight for age z-score

Secondary Outcome Measures

Name	Time	Method
Incidence of respiratory infection between study groups	Study Day 1 to 24 Months of Age	Adverse event reports
Number of respiratory infection episodes between study groups	Study Day 1 to 24 Months of Age	Adverse event reports
Incidence of infection morbidity between study groups	Study Day 1 to 24 Months of Age	Adverse event reports
Number of episodes of infection morbidity between study groups	Study Day 1 to 24 Months of Age	Adverse event reports
Weight	Study Day 1 to 24 Months of Age	Interval weight gain per day
Length	Study Day 1 to 24 Months of Age	Interval length gain per day
Head Circumference	Study Day 1 to 24 Months of Age	Interval head circumference gain per day
Gastrointestinal Tolerance	Study Day 1 to 12 months of Age	Parent completed diary

Trial Locations

Locations (42)

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

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