Status:
ACTIVE_NOT_RECRUITING
Enfamil NeuroPro Study
Lead Sponsor:
University of Arizona
Collaborating Sponsors:
Mead Johnson Nutrition
Conditions:
Infant Development
Infant ALL
Eligibility:
All Genders
Up to 4 years
Phase:
NA
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 brea...
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 f...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 5 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 31 2026
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT06059209
Start Date
January 5 2023
End Date
May 31 2026
Last Update
December 11 2025
Active Locations (1)
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1
University of Arizona
Tucson, Arizona, United States, 85724