Enfamil NeuroPro Study

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

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.

Study Overview

• Status: Recruiting
• Conditions: Infant ALL; Infant Development
• Intervention / Treatment: Dietary supplement: Enfamil Infant; Dietary supplement: Enfamil NeuroPro

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.

• Study Type: Interventional
• Enrollment (Estimated): 240
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nikki Reed, MS; Phone Number: (520) 626-3414; Email: nikkireed23@arizona.edu
• Study Contact Backup: Name: Fayez Ghishan, MD; Phone Number: 520-694-6000

Study Locations

• United States
  • Arizona
    • Tucson, Arizona, United States, 85724
      • Recruiting
      • University of Arizona
      • Contact: Nikki Reed, MD; Phone Number: 520-626-3414; Email: nikkireed23@arizona.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Breast Milk
Other: Enfamil Infant	Dietary supplement: Enfamil Infant; FDA Infant formula
Active Comparator: Enfamil NeuroPro	Dietary supplement: Enfamil NeuroPro; FDA Infant formula

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in microbial DNA in term infants fed Enfamil NeuroPro as compared to standard Enfamil Infant formula or breast milk.	Assessed using 16S amplicon profiling of stool samples	Birth to 4 months
Change from baseline in the gut metagenomics in term infants fed Enfamil NeuroPro as compared to standard Enfamil Infant formula or breast milk.	Samples sequenced using the NextSeq 500/550 and mapped against functional reference sequence databases using Bowtie2	Birth to 4 months
Change from baseline of metabolome in term infants fed Enfamil NeuroPro as compared to standard Enfamil Infant formula or breast milk.	Untargeted analysis by automated comparison of the ion features in the experimental samples to a reference library of chemical standard entries.	Birth to 4 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Growth- Height	Measured periodically in centimeters as part of routine care	Birth to 4 months
Growth- Head circumference	Measured periodically in centimeters as part of routine care	Birth to 4 months
Growth- Weight	Measured periodically in kg as part of routine care	Birth to 4 months

Collaborators and Investigators

• Sponsor: University of Arizona
• Collaborators: Mead Johnson Nutrition

Study record dates

Study Major Dates

• Study Start (Actual): January 5, 2023
• Primary Completion (Estimated): September 1, 2024
• Study Completion (Estimated): February 1, 2025

Study Registration Dates

• First Submitted: August 30, 2023
• First Submitted That Met QC Criteria: September 22, 2023
• First Posted (Actual): September 28, 2023

Study Record Updates

• Last Update Posted (Actual): September 28, 2023
• Last Update Submitted That Met QC Criteria: September 22, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Healthy Infants
• Other Study ID Numbers: STUDY00000917

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data and specimens will not be stored for future research.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No