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OpenTrials
Completed

NCT Number: NCT03493711

Differences Between Breastfed and Formula Fed Infants

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

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Key information

Conditions

Healthy

Age range

2 month–3 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Arkansas Children's Nutrition Center

Little Rock, Arkansas, 72202, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. The role of microbiota in gut

    Time frame: 2.5-3 months

    Stool samples will be collected

  2. The role of microbiota in immune system development

    Time frame: 2.5-3 months

    Stool samples will be collected

Sponsors and collaborators

Lead sponsor

Arkansas Children's Hospital Research Institute

Other

Registry information

Official study title

Microbiota Differences Between Breastfed and Formula Fed Infants

Important dates

Study start
2018
Primary completion
2024
Study completion
2024
First posted
Apr 10, 2018
Registry last updated
Feb 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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