Enfamil NeuroPro Study

University of Arizona

Status

Enrolling

Conditions

Infant ALL

Infant Development

Treatments

Dietary Supplement: Enfamil Infant

Dietary Supplement: Enfamil NeuroPro

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT06059209

STUDY00000917

Details and patient eligibility

About

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.

Full 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.

Enrollment

240 estimated patients

Sex

All

Ages

Under 4 months old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Healthy term infants with parental consent
Parents are able to provide informed consent; own a smart phone and are able to fill out weekly digital questionnaires.

Exclusion criteria

Prematurity (<= 36 weeks gestational age)
Babies born through c-section
Any health issues identified at the first postpartum screening
Use of both breast milk and formula
Use of donor breast milk
Parent unwillingness/inability to avoid giving prebiotics, probiotics, symbiotics, and immune-stimulating products to the child for the duration of this study