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

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.

Conditions

• Growth

Interventions

OTHER

Control Infant Formula

Ad libitum or as instructed by HCP, feeding period from enrollment to 12 months of age

OTHER

Control Toddler Drink

\~ 16 fl oz per day as primary milk beverage; feeding period from 12 to 24 months of age

OTHER

Experimental Infant Formula

Ad libitum or as instructed by HCP, feeding period from enrollment to 12 months of age

OTHER

Experimental Toddler Drink

\~ 16 fl oz per day as primary milk beverage; feeding period from 12 to 24 months of age

OTHER

Human Milk

Ad libitum or as instructed by HCP

OTHER

Human Milk Supplemental Formula

Ad libitum if consuming supplemented formula; feeding period up to 12 months of age

OTHER

Human Milk Toddler Drink

\~16 fl oz per day if providing supplemental nutrition other than HM; feeding period from 12 to 24 months of age

Sponsors & Collaborators

• Abbott Nutrition

  lead INDUSTRY

Principal Investigators

• Elizabeth Reverri, PhD, MS, RD · Abbott Nutrition

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

0 Days

Max Age

14 Days

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2021-07-21

Primary Completion

2025-05-12

Completion

2025-05-12

Countries

• United States

Study Locations