Comparing gut bacteria in infants fed different formulas and breast milk
The Role of Milk Fat Globule Membrane and 2'-Fucosyllactose in the Infant Gut Microbiota
This study looks at how different feeding methods, like standard formula, a new formula that mimics breast milk, and breastfeeding, affect the gut bacteria of healthy infants from birth to 4 months old.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 240 (estimated) |
| Ages | 0 Months to 4 Months |
| Sex | All |
| Sponsor | University of Arizona Academic / other |
| Locations | 1 site (Tucson, Arizona) |
| Trial ID | NCT06059209 on ClinicalTrials.gov |
What this trial studies
This study compares the gut bacteria of healthy infants fed either a standard infant formula, Enfamil Infant, a new formula designed to mimic breast milk, Enfamil NeuroPro, or breastfed infants. It is a randomized, double-blind, parallel-group study that will analyze fecal samples collected from birth to 4 months of age to assess the impact of these feeding methods on the microbiome. The study aims to determine if the addition of specific components in the Enfamil NeuroPro formula influences gut health similarly to breast milk. Investigators will also evaluate growth parameters and indicators of inflammation and intestinal barrier function.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy term infants whose parents can provide informed consent and complete weekly digital questionnaires.
Not a fit: Patients who may not benefit from this study include premature infants, those born via c-section, or infants with health issues identified at postpartum screening.
Why it matters
Potential benefit: If successful, this study could provide insights into how infant formula can be improved to better support healthy gut development in infants.
How similar studies have performed: Other studies have shown promising results in understanding the impact of infant feeding methods on gut microbiota, making this approach both relevant and potentially beneficial.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Tucson, Arizona
- University of Arizona — Tucson, Arizona, United States (Recruiting)
Study contacts
- Study coordinator: Nikki Reed, MS
- Email: nikkireed23@arizona.edu
- Phone: (520) 626-3414
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.