Differences Between Breastfed and Formula Fed Infants

Completed

• Conditions: Healthy

• Registration Number: NCT03493711
• Lead Sponsor: Arkansas Children's Hospital Research Institute

Brief Summary

This study will help us learn how a child's diet affects growth and development.

Detailed Description

This study will see how infants diet affects their growth and development. Up to 170 infants will be enrolled for one visit.

Study Timeline

• Study First Submitted: 2018-02-12
• Study Start: 2018-02-21
• Study First Submitted QC: 2018-04-09
• Study First Posted: 2018-04-10
• Primary Completion: 2024-08-06
• Study Completion: 2024-08-06
• Status Verified: 2025-01
• Last Update Submitted: 2025-02-13
• Last Update Posted: 2025-02-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 158

Inclusion Criteria

• Exclusive breast feeding or cow milk formula feeding during the first 3 months of life.
• For formula feeders, exclusively on Similac Advance Formula for at least 1 month prior to visit
• Age 2.5-3.5 months

Exclusion Criteria

• Infants born to mother with preexisting medical conditions.
• Infants born to mother with medications during pregnancy known to influence fetal growth.
• Infants born to smoking, alcohol drinking or drug use mothers during pregnancy.
• Preterm

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The role of microbiota in immune system development	2.5-3 months	Stool samples will be collected
The role of microbiota in gut	2.5-3 months	Stool samples will be collected

Trial Locations

Locations (1)

Arkansas Children's Nutrition Center; 🇺🇸 Little Rock, Arkansas, United States