Differences Between Breastfed and Formula Fed Infants | NCT03493711

Studies
Differences Between Breastfed and Formula Fed Infants

NCT03493711

Sponsor

Arkansas Children's Hospital Research Institute

Status

Completed

Last Update Posted

Feb 14, 2025Actual

Enrollment

158Actual

Phase

Not provided

Conditions

Healthy

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 21, 2018Actual

Primary Completion Date

Aug 6, 2024Actual

Completion Date

Aug 6, 2024Actual

First Submitted Date

Feb 12, 2018

First Submission Date that Met QC Criteria

Apr 9, 2018

First Posted Date

Apr 10, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 13, 2025

Last Update Posted Date

Feb 14, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

158Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Interventions

Not provided

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

2 Months

Maximum Age

3 Months

Standard Ages

Child

Study Population

Infants

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Aline Andres, PhD, RD	Arkansas Children's Nutrition Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Arkansas Children's Nutrition Center		Little Rock	Arkansas	72202	United States