NCT04957992

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

Infant Formula and Toddler Drink Feeding Intervention Through 24 Months of Age

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 607 (actual)
• Sponsor: Abbott Nutrition · Industry
• Sex: All
• Age: 0 Days – 14 Days
• Healthy volunteers: Accepted

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

Type	Name	Description
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

Timeline

• Start date: 2021-07-21
• Primary completion: 2025-05-12
• Completion: 2025-05-12
• First posted: 2021-07-12
• Last updated: 2025-06-27

Locations

42 sites across 1 country: United States