Enfamil NeuroPro Study

N/AActive Not RecruitingNCT06059209

University of Arizona240 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Enrollment

240

Conditions

Infant Development Infant ALL

Interventions

Enfamil NeuroProDIETARY_SUPPLEMENT

FDA Infant formula

Enfamil InfantDIETARY_SUPPLEMENT

FDA Infant formula

Eligibility

Sex: ALLMin age: 0 MonthsMax age: 4 MonthsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

University of Arizona

Tucson, Arizona, United States

Outcomes

Primary Outcomes

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

Time frame: 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

Time frame: 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.

Time frame: Birth to 4 months

Secondary Outcomes

Growth- Height

Measured periodically in centimeters as part of routine care

Time frame: Birth to 4 months

Growth- Head circumference

Measured periodically in centimeters as part of routine care

Time frame: Birth to 4 months

Growth- Weight

Measured periodically in kg as part of routine care

Time frame: Birth to 4 months

Data from ClinicalTrials.gov

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