Enfamil NeuroPro Study

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06059209
Study type	Interventional
Source	University of Arizona
Contact	Nikki Reed, MS
Phone	(520) 626-3414
Email	nikkireed23@arizona.edu
Status	Recruiting
Phase	N/A
Start date	January 5, 2023
Completion date	February 1, 2025

View Details

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