Infant ALL, Infant Development
Conditions
Keywords
Healthy Infants
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.
Interventions
DIETARY_SUPPLEMENTEnfamil NeuroPro
FDA Infant formula
DIETARY_SUPPLEMENTEnfamil Infant
FDA Infant formula
Sponsors
Mead Johnson Nutrition
University of Arizona
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Masking description
Participants and research nurse/coordinator will be blinded to the formula assignment. The formulas used will be a standard infant formula (Enfamil Infant) and a new infant formula designed to be more similar to breast milk (Enfamil NeuroPro); both formulas are available for purchase by the public and meet FDA requirements for infant formulas. Each formula can (identical size) will be relabeled and coded by the investigators. Participants in the formula group will be provided with a four-month supply of powdered formula at the time of discharge from the hospital, along with stool collection kits.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
0 Months to 4 Months
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Growth- Weight | Birth to 4 months | Measured periodically in kg as part of routine care |
| Growth- Head circumference | Birth to 4 months | Measured periodically in centimeters as part of routine care |
| Growth- Height | Birth to 4 months | Measured periodically in centimeters as part of routine care |
Countries
United States
Outcome results
None listed