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| Name | Class |
|---|---|
| Mead Johnson Nutrition | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Breast Milk | No Intervention | ||
| Enfamil Infant | Other |
| |
| Enfamil NeuroPro | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enfamil NeuroPro | Dietary Supplement | FDA Infant formula |
| |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Arizona | Tucson | Arizona | 85724 | United States |
Data and specimens will not be stored for future research.
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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.
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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.
| Enfamil Infant |
| Dietary Supplement |
FDA Infant formula |
|
| Birth to 4 months |
| Growth- Weight | Measured periodically in kg as part of routine care | Birth to 4 months |