NCT06059209

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
240

participants targeted

Target at P75+ for not_applicable

Timeline
0mo left

Started Jan 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress98%
Jan 2023May 2026

Study Start

First participant enrolled

January 5, 2023

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 30, 2023

Completed
29 days until next milestone

First Posted

Study publicly available on registry

September 28, 2023

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 26, 2025

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2026

Expected
Last Updated

December 11, 2025

Status Verified

December 1, 2025

Enrollment Period

2.6 years

First QC Date

August 30, 2023

Last Update Submit

December 10, 2025

Conditions

Infant DevelopmentInfant ALL

Keywords

Healthy Infants

Outcome Measures

Primary Outcomes (3)

  • 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

Secondary Outcomes (3)

  • Growth- Height

    Birth to 4 months

  • Growth- Head circumference

    Birth to 4 months

  • Growth- Weight

    Birth to 4 months

Study Arms (3)

Breast Milk

NO INTERVENTION

Enfamil Infant

OTHER
Dietary Supplement: Enfamil Infant

Enfamil NeuroPro

ACTIVE COMPARATOR
Dietary Supplement: Enfamil NeuroPro

Interventions

Enfamil NeuroProDIETARY_SUPPLEMENT

FDA Infant formula

Enfamil NeuroPro
Enfamil InfantDIETARY_SUPPLEMENT

FDA Infant formula

Enfamil Infant

Eligibility Criteria

Age0 Months - 4 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Arizona

Tucson, Arizona, 85724, United States

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
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.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 30, 2023

First Posted

September 28, 2023

Study Start

January 5, 2023

Primary Completion

August 26, 2025

Study Completion (Estimated)

May 31, 2026

Last Updated

December 11, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Data and specimens will not be stored for future research.

Locations

US(1)