Differences Between Breastfed and Formula Fed Infants

December 18, 2023 updated by: Arkansas Children's Hospital Research Institute

Microbiota Differences Between Breastfed and Formula Fed Infants

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

Study Overview

Status

Active, not recruiting

Conditions

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 Type

Observational

Enrollment (Actual)

158

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72202
        • Arkansas Children's Nutrition Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 months to 3 months (Child)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Infants

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Breast Fed
Exclusively breastfed for first 3 months of life
Milk-based formula fed
Exclusively on Similac Advance Formula for at least 1 month prior to visit

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The role of microbiota in gut
Time Frame: 2.5-3 months
Stool samples will be collected
2.5-3 months
The role of microbiota in immune system development
Time Frame: 2.5-3 months
Stool samples will be collected
2.5-3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Arkansas Children's Hospital Research Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 21, 2018

Primary Completion (Estimated)

June 1, 2024

Study Completion (Estimated)

June 1, 2024

Study Registration Dates

First Submitted

February 12, 2018

First Submitted That Met QC Criteria

April 9, 2018

First Posted (Actual)

April 10, 2018

Study Record Updates

Last Update Posted (Actual)

December 21, 2023

Last Update Submitted That Met QC Criteria

December 18, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 217562

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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