MedPath

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

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
NameTimeMethod
GrowthStudy Day 1 to 6 Months of Age

weight for age z-score

Secondary Outcome Measures
NameTimeMethod
Incidence of respiratory infection between study groupsStudy Day 1 to 24 Months of Age

Adverse event reports

Number of respiratory infection episodes between study groupsStudy Day 1 to 24 Months of Age

Adverse event reports

Incidence of infection morbidity between study groupsStudy Day 1 to 24 Months of Age

Adverse event reports

Number of episodes of infection morbidity between study groupsStudy Day 1 to 24 Months of Age

Adverse event reports

WeightStudy Day 1 to 24 Months of Age

Interval weight gain per day

LengthStudy Day 1 to 24 Months of Age

Interval length gain per day

Head CircumferenceStudy Day 1 to 24 Months of Age

Interval head circumference gain per day

Gastrointestinal ToleranceStudy 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

Scroll for more (32 remaining)
MedPharmics, LLC 3192
🇺🇸Phoenix, Arizona, United States

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.