Enfamil NeuroPro Study

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.

Basic eligibility criteria:
Please contact the study coordinator for additional eligibility information.

Inclusion criteria:

Healthy term infants 37-42 weeks gestational age with parental consent. Their parent(s) will also be recruited to complete questionnaires about their babies’ health. No exclusion based on gender or ethnicity. Infants will be enrolled at birth and will continue participation through 4 months. For the formula groups, participants will only be eligible if infant's mother is unable or unwilling to breastfeed and has made the decision to exclusively formula feed. Participants will be given 7-10 days after discharge to decide to enroll in the study.

Exclusion criteria:

  • prematurity (<= 36 weeks gestational age)
  • babies born through c-section
  • any health issues identified at the first postpartum screening
  • on-going 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 

Additional information:

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.

Primary disease category: Children, Infants & Newborns

Secondary disease categories: Digestive System

This study is enrolling healthy volunteers.

Sponsor: Mead Johnson Nutrition

Protocol number: STUDY00000917

Projected enrollment dates: February 2024 to February 2027

Official study title: The Role of Milk Fat Globule Membrane and 2’Fucosyllactose in the Infant Gut Microbiota

External link(s):
ClinicalTrials.gov ID: NCT06059209

ClinicalTrials.gov page:
http://www.clinicaltrials.gov/show/NCT06059209