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NCT03493711 Clinical Trial

Differences Between Breastfed and Formula Fed Infants

Healthy Clinical Trial

Official title:
Microbiota Differences Between Breastfed and Formula Fed Infants

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT03493711
Other study ID # 217562
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date February 21, 2018
Est. completion date June 2024

Study information
Verified date December 2023
Source Arkansas Children's Hospital Research Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 158
Est. completion date June 2024
Est. primary completion date June 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 2 Months to 3 Months
Eligibility 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

Related Conditions & MeSH terms

Locations
Country Name City State
United States Arkansas Children's Nutrition Center Little Rock Arkansas

Sponsors (1)
Lead Sponsor Collaborator
Arkansas Children's Hospital Research Institute

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary The role of microbiota in gut Stool samples will be collected 2.5-3 months
Primary The role of microbiota in immune system development Stool samples will be collected 2.5-3 months
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