Enfamil NeuroPro Study

Infant Development Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06059209
• Other study ID #: STUDY00000917
• Status: Recruiting
• Phase: N/A
• Start date: January 5, 2023
• Est. completion date: February 1, 2025

Study information

• Verified date: August 2023
• Source: University of Arizona
• Contact: Nikki Reed, MS
• Phone: (520) 626-3414
• Email: nikkireed23[@]arizona.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: February 1, 2025
• Est. primary completion date: September 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 0 Months to 4 Months

Eligibility

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

Related Conditions & MeSH terms

• Infant ALL
• Infant Development

Intervention

Dietary Supplement:
• Enfamil NeuroPro
FDA Infant formula
• Enfamil Infant
FDA Infant formula

Locations

Country	Name	City	State
United States	University of Arizona	Tucson	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
University of Arizona	Mead Johnson Nutrition

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Growth- Height	Measured periodically in centimeters as part of routine care	Birth to 4 months
Secondary	Growth- Head circumference	Measured periodically in centimeters as part of routine care	Birth to 4 months
Secondary	Growth- Weight	Measured periodically in kg as part of routine care	Birth to 4 months