Breastfeeding Study | NCT03387124

Studies
Breastfeeding Study

NCT03387124

Sponsor

Société des Produits Nestlé (SPN)

Status

Completed

Last Update Posted

Apr 24, 2019Actual

Enrollment

75Actual

Phase

Not provided

Conditions

Infant Term Birth

Interventions

Breastfed infants

Countries

Philippines

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

Apr 2019

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

Jan 22, 2018Actual

Primary Completion Date

Oct 24, 2018Actual

Completion Date

Dec 11, 2018Actual

First Submitted Date

Dec 21, 2017

First Submission Date that Met QC Criteria

Dec 21, 2017

First Posted Date

Dec 29, 2017Actual

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

Apr 23, 2019

Last Update Posted Date

Apr 24, 2019Actual

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

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to evaluate the stool consistency and microbiota composition of healthy breastfed infants.

Detailed Description

This is a prospective, observational, non-interventional study. The purpose of this study is to evaluate the stool consistency and variability in fecal microbiota composition, diversity, and abundance of defined taxa in 75 healthy, term, exclusively breastfed infants. All enrolled infants will participate in the trial for approximately 169 days.

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

No data available

No data is available for this block.

Enrollment

75Actual

Name	Type	Description	Arm Group Labels	Other Names
Breastfed infants	Other	Breastmilk

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Stool Consistency Score		155 days

Secondary Outcomes

Measure	Description	Time Frame
Fecal Microbiota Composition		155 days
Changes in Weight from baseline to 155 days	weight (kg)	155 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Written informed consent
Infants whose parent(s)/LAR who have reached the legal age of majority in the Philippines
Infants whose parent(s)/LAR are willing and able to comply with study requirements
Infants whose parent(s)/LAR who are able to be contacted directly by telephone throughout the study
Healthy term, singleton infant at birth
Between 21 to 26 days post-natal age at enrollment visit
Weight-for-length and head circumference-for-age z-scores are ≥ -3 and ≤ +3 according to WHO Child Growth Standards
Infants of parent(s)/LAR who have previously made the decision to breastfeed their infant at the time of enrollment

Exclusion Criteria:

Infants with conditions requiring infant feedings other than those specified in the protocol
Infants receiving weaning foods or liquids
Infants who have a medical condition or history that could increase the risk associated with study participation or interfere with the interpretation of study results
Infants who are presently receiving or have received medications that could interfere with the interpretation of study results
Infants or infants whose parent(s)/LAR who cannot be expected to comply with the protocol or with study procedures

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Days

Maximum Age

26 Days

Standard Ages

Child

Study Population

75 healthy term exclusively breastfed infants

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
Elvira M Estorninos, MD	University of Alberta	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Asian Hospital and Medical Center		City of Muntinlupa	Alabang	1780	Philippines

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
36243744	Derived	Samuel TM, Hartweg M, Lebumfacil JD, Buluran KB, Lawenko RB, Estorninos EM, Binia A, Sprenger N. Dynamics of human milk oligosaccharides in early lactation and relation with growth and appetitive traits of Filipino breastfed infants. Sci Rep. 2022 Oct 15;12(1):17304. doi: 10.1038/s41598-022-22244-7.