Clinical trial NCT06059209: Enfamil NeuroPro Study
Official title: The Role of Milk Fat Globule Membrane and 2'-Fucosyllactose in the Infant Gut Microbiota
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Infant Development
Infant ALL
Keywords: Healthy Infants
Lead sponsor: University of Arizona
Sponsor class: OTHER
Collaborators: name: Mead Johnson Nutrition
First posted: 2023-09-28
Enrollment: 240
Sex: ALL
Minimum age (years): 0
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline in microbial DNA in term infants fed Enfamil NeuroPro as compared to standard Enfamil Infant formula or breast milk.
timeFrame: Birth to 4 months
measure: Change from baseline in the gut metagenomics in term infants fed Enfamil NeuroPro as compared to standard Enfamil Infant formula or breast milk.
timeFrame: Birth to 4 months
measure: Change from baseline of metabolome in term infants fed Enfamil NeuroPro as compared to standard Enfamil Infant formula or breast milk.
timeFrame: Birth to 4 months
Secondary outcomes:
measure: Growth- Height
timeFrame: Birth to 4 months
measure: Growth- Head circumference
timeFrame: Birth to 4 months
measure: Growth- Weight
timeFrame: Birth to 4 months
Other outcomes:
Locations:
city: Tucson
country: United States
facility: University of Arizona
state: Arizona
Study officials:
References: