← Back to Search

Dietary Supplement

Enfamil NeuroPro for Infant Gut Health

N/A

Recruiting

Research Sponsored by University of Arizona

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up birth to 4 months

Awards & highlights

Study Summary

This trial will compare gut bacteria in breastfed, formula-fed, and a new formula-fed infants to see how they differ.

Who is the study for?

This trial is for healthy, full-term infants with parents who consent to participate. Parents must be able to give informed consent, own a smartphone, and complete weekly digital questionnaires. Infants born prematurely or via c-section, those with health issues at postpartum screening, or receiving prebiotics/probiotics/symbiotics/immune products are excluded.Check my eligibility

What is being tested?

The study compares the gut bacteria in infants fed standard formula (Enfamil Infant), a new formula similar to breast milk (Enfamil NeuroPro), and breastfed infants. All formulas used meet FDA requirements and are commercially available.See study design

What are the potential side effects?

Since both Enfamil Infant and Enfamil NeuroPro are FDA-approved formulas already on the market, significant side effects aren't expected. However, individual responses can vary; some babies might experience digestive changes when switching formulas.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ birth to 4 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~birth to 4 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and birth to 4 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change from baseline in microbial DNA in term infants fed Enfamil NeuroPro as compared to standard Enfamil Infant formula or breast milk.

Change from baseline in the gut metagenomics in term infants fed Enfamil NeuroPro as compared to standard Enfamil Infant formula or breast milk.

Change from baseline of metabolome in term infants fed Enfamil NeuroPro as compared to standard Enfamil Infant formula or breast milk.

Secondary outcome measures

Growth- Head circumference

Growth- Height

Growth- Weight

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Enfamil InfantExperimental Treatment1 Intervention

Group II: Enfamil NeuroProActive Control1 Intervention

Group III: Breast MilkActive Control1 Intervention

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of ArizonaLead Sponsor

515 Previous Clinical Trials

148,474 Total Patients Enrolled

Mead Johnson NutritionIndustry Sponsor

79 Previous Clinical Trials

16,128 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the upper limit for participant numbers in this trial?

"Affirmative. According to clinicaltrials.gov, this trial is still looking for participants and was first posted on May 1st 2023. The data has been updated as recently as September 22nd 2023, and the researchers need 240 people from one site location."

Answered by AI

Does this experiment permit elderly participation?

"The eligibility guidelines for this experimental trial stipulate that the youngest participant should be 0 Months old and no older than 4 Months."

Answered by AI

Is it possible for me to volunteer my participation in this clinical research?

"Participants must have infant development and be in the 0-4 month age bracket to join this trial. An approximate 240 subjects are required for successful enrolment."

Answered by AI

Are there any spots open for participation in this scientific investigation?

"Affirmative. Clinicaltrials.gov indicates that this medical trial is actively recruiting patients since its inception on the 5th of January 2023, with a most recent update being logged on September 22nd 20203. A total of 240 participants from one single location are required for completion of this study."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Enfamil NeuroPro Study

2023. "Enfamil NeuroPro Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06059209.

All > Tucson