Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT06059209

Enfamil NeuroPro Study

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Age range

0 month–4 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Arizona

Tucson, Arizona, 85724, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Enfamil NeuroPro

Dietary Supplement

FDA Infant formula

Enfamil Infant

Dietary Supplement

FDA Infant formula

Primary outcomes

  1. Change from baseline in microbial DNA in term infants fed Enfamil NeuroPro as compared to standard Enfamil Infant formula or breast milk.

    Time frame: Birth to 4 months

    Assessed using 16S amplicon profiling of stool samples

  2. Change from baseline in the gut metagenomics in term infants fed Enfamil NeuroPro as compared to standard Enfamil Infant formula or breast milk.

    Time frame: Birth to 4 months

    Samples sequenced using the NextSeq 500/550 and mapped against functional reference sequence databases using Bowtie2

  3. Change from baseline of metabolome in term infants fed Enfamil NeuroPro as compared to standard Enfamil Infant formula or breast milk.

    Time frame: Birth to 4 months

    Untargeted analysis by automated comparison of the ion features in the experimental samples to a reference library of chemical standard entries.

Secondary outcomes

  1. Growth- Height

    Time frame: Birth to 4 months

    Measured periodically in centimeters as part of routine care

  2. Growth- Head circumference

    Time frame: Birth to 4 months

    Measured periodically in centimeters as part of routine care

  3. Growth- Weight

    Time frame: Birth to 4 months

    Measured periodically in kg as part of routine care

Sponsors and collaborators

Lead sponsor

University of Arizona

Other

Collaborators

  • Mead Johnson Nutrition

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Sep 28, 2023
Registry last updated
Dec 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.