Enfamil NeuroPro Study

Not Applicable

Recruiting

• Conditions: Infant Development; Infant ALL
• Interventions: Dietary Supplement: Enfamil NeuroPro; Dietary Supplement: Enfamil Infant

• Registration Number: NCT06059209
• Lead Sponsor: University of Arizona

Brief 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.

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 Timeline

• Study Start: 2023-01-05
• Status Verified: 2023-08
• Study First Submitted: 2023-08-30
• Study First Submitted QC: 2023-09-22
• Last Update Submitted: 2023-09-22
• Study First Posted: 2023-09-28
• Last Update Posted: 2023-09-28
• Primary Completion: 2024-09-01
• Study Completion: 2025-02-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 240

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Enfamil NeuroPro	Enfamil NeuroPro	-
Enfamil Infant	Enfamil Infant	-

Primary Outcome Measures

Name	Time	Method
Change from baseline in microbial DNA in term infants fed Enfamil NeuroPro as compared to standard Enfamil Infant formula or breast milk.	Birth to 4 months	Assessed using 16S amplicon profiling of stool samples
Change from baseline in the gut metagenomics in term infants fed Enfamil NeuroPro as compared to standard Enfamil Infant formula or breast milk.	Birth to 4 months	Samples sequenced using the NextSeq 500/550 and mapped against functional reference sequence databases using Bowtie2
Change from baseline of metabolome in term infants fed Enfamil NeuroPro as compared to standard Enfamil Infant formula or breast milk.	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 Outcome Measures

Name	Time	Method
Growth- Weight	Birth to 4 months	Measured periodically in kg as part of routine care
Growth- Height	Birth to 4 months	Measured periodically in centimeters as part of routine care
Growth- Head circumference	Birth to 4 months	Measured periodically in centimeters as part of routine care

Trial Locations

Locations (1)

University of Arizona; 🇺🇸 Tucson, Arizona, United States