Enfamil NeuroPro Study

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Infant Development, Infant ALL

Intervention / Treatment
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* Dietary Supplement: Enfamil NeuroPro
* Dietary Supplement: Enfamil Infant


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 0 Months
Maximum Age: 4 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Subjects will be able to choose between the breast-fed or formula-fed group. Subjects in the formula-fed group will be randomly assigned to one of the two formulas, with a 50% chance of being assigned to each group.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Breast Milk<br> | |
| Other: Enfamil Infant<br> | Dietary Supplement: Enfamil Infant<br>* FDA Infant formula<br>|
| Active Comparator: Enfamil NeuroPro<br> | Dietary Supplement: Enfamil NeuroPro<br>* FDA Infant formula<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Healthy Infants