Differences Between Breastfed and Formula Fed Infants

Sponsor
Arkansas Children's Hospital Research Institute (Other)
Overall Status
Recruiting
CT.gov ID
NCT03493711
Collaborator
(none)
120
Enrollment
1
Location
75.3
Anticipated Duration (Months)
1.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or DiseaseIntervention/TreatmentPhase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    120 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Microbiota Differences Between Breastfed and Formula Fed Infants
    Actual Study Start Date :
    Feb 21, 2018
    Anticipated Primary Completion Date :
    Jun 1, 2024
    Anticipated Study Completion Date :
    Jun 1, 2024

    Arms and Interventions

    ArmIntervention/Treatment
    Breast Fed

    Exclusively breastfed for first 3 months of life

    Milk-based fomula fed

    Exclusively on Similac Advance Formula for at least 1 month prior to visit

    Outcome Measures

    Primary Outcome Measures

    1. The role of microbiota in gut [2.5-3 months]

      Stool samples will be collected

    2. The role of microbiota in immune system development [2.5-3 months]

      Stool samples will be collected

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    2 Months to 3 Months
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1Arkansas Children's Nutrition CenterLittle RockArkansasUnited States72202

    Sponsors and Collaborators

    • Arkansas Children's Hospital Research Institute

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Arkansas Children's Hospital Research Institute
    ClinicalTrials.gov Identifier:
    NCT03493711
    Other Study ID Numbers:
    • 217562
    First Posted:
    Apr 10, 2018
    Last Update Posted:
    Oct 8, 2021
    Last Verified:
    Oct 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Oct 8, 2021