Enfamil NeuroPro Study

Last updated: December 10, 2025
Sponsor: University of Arizona
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

N/A

Treatment

Enfamil Infant

Enfamil NeuroPro

Clinical Study ID

NCT06059209
STUDY00000917
  • Ages < 4
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Healthy term infants with parental consent

  • Parents are able to provide informed consent; own a smart phone and are able to fillout weekly digital questionnaires.

Exclusion

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

Study Design

Total Participants: 240
Treatment Group(s): 2
Primary Treatment: Enfamil Infant
Phase:
Study Start date:
January 05, 2023
Estimated Completion Date:
May 31, 2026

Study 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.

Connect with a study center

  • University of Arizona

    Tucson, Arizona 85724
    United States

    Site Not Available

  • University of Arizona

    Tucson 5318313, Arizona 5551752 85724
    United States

    Site Not Available

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