Safety and Efficacy Study | NCT02670863

Studies
Safety and Efficacy Study

NCT02670863

Sponsor

Société des Produits Nestlé (SPN)

Status

Completed

Last Update Posted

Oct 11, 2021Actual

Enrollment

239Actual

Phase

Not Applicable

Conditions

Infant Term Birth

Interventions

Experimental Infant Formula
Standard Infant Formula

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

Oct 2021

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 21, 2016Actual

Primary Completion Date

Mar 2017Actual

Completion Date

May 2017Actual

First Submitted Date

Jan 20, 2016

First Submission Date that Met QC Criteria

Jan 29, 2016

First Posted Date

Feb 2, 2016Estimated

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

Oct 4, 2021

Last Update Posted Date

Oct 11, 2021Actual

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 safety and efficacy of the experimental formula supplemented with a prebiotic vs the control formula.

Detailed Description

Randomized, double-blind, controlled interventional clinical trial design. The purpose of this study is to evaluate the safety and efficacy of a new term infant formula supplemented with a prebiotic vs a standard infant formula fed for 150 days to healthy, term infants.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

239Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Experimental Infant Formula	Experimental	Experimental Infant Formula containing a prebiotic	Other: Experimental Infant Formula
Standard Infant Formula	Active Comparator	Standard bovine milk-based term infant formula	Other: Standard Infant Formula

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Experimental Infant Formula	Other	Standard bovine milk-based term infant formula supplemented with a prebiotic, fed ad libitum	Experimental Infant Formula

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Growth	weight gain velocity	150 days
Stool Consistency Score		150 days

Secondary Outcomes

Measure	Description	Time Frame
Weight	weight in grams	150 days
Average Daily Stool Frequency		150 days
Fecal Microbiota

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Written Informed Consent
Infants whose parent(s)/LAR 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 are able to be contacted 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 >/= - 3 and \

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

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Elvira M Estorninos, MD	Asian Hospital and Medical Center	Principal Investigator

Locations

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

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided