NCT06059209

Enfamil NeuroPro Study

The Role of Milk Fat Globule Membrane and 2'-Fucosyllactose in the Infant Gut Microbiota

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 240 (estimated)
• Sponsor: University of Arizona · Academic / Other
• Sex: All
• Age: 0 Months – 4 Months
• Healthy volunteers: Accepted

Summary

This study will compare infant gut bacteria for infants who have been fed a standard infant formula (Enfamil Infant); infants who have been fed a new infant formula designed to be more similar to breast milk (Enfamil NeuroPro); and breastfed infants. These formulas are currently available on the market and meet FDA requirements for infant formula.

Detailed description

This study is a randomized, double-blind, parallel-group study comparing breast milk to Enfamil Infant and Enfamil NeuroPro formulas. The central hypothesis of the study is that the addition of milk fat globule membrane and2'-Fucosyllactose (2'-FL) to infant formula plays a role in shaping the microbiota in a manner similar to the microbiota of breastfed infants. To test this hypothesis, the investigators will explore longitudinal changes in the fecal microbiome from birth to 4 months of age in infants fed breast-milk, standard Enfamil Infant formula or Enfamil NeuroPro formula. Fecal samples will be collected at birth, and then monthly for 4 months. At the time of last collection one serum sample will be collected. The investigators will analyze basic growth parameters, fecal microbial community analysis by metagenomics, fecal metabolome by untargeted metabolomic analysis, and fecal and systemic indicators of inflammation and intestinal barrier function.

Conditions

• Infant Development
• Infant ALL

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Enfamil NeuroPro	FDA Infant formula
DIETARY_SUPPLEMENT	Enfamil Infant	FDA Infant formula

Timeline

• Start date: 2023-01-05
• Primary completion: 2025-08-26
• Completion: 2026-05-31
• First posted: 2023-09-28
• Last updated: 2025-12-11

Locations

1 site across 1 country: United States