Probiotic Formula and Infant Growth | NCT01476397

Studies
Probiotic Formula and Infant Growth

NCT01476397

Sponsor

Société des Produits Nestlé (SPN)

Status

Completed

Last Update Posted

Nov 4, 2014Estimated

Enrollment

Not provided

Phase

Not Applicable

Conditions

Healthy

Interventions

Control infant formula
Test infant formula

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

Nov 2014

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

Dec 2011

Primary Completion Date

Jun 2013Actual

Completion Date

Oct 2013Actual

First Submitted Date

Nov 14, 2011

First Submission Date that Met QC Criteria

Nov 17, 2011

First Posted Date

Nov 22, 2011Estimated

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

Nov 3, 2014

Last Update Posted Date

Nov 4, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

This is a growth study of full-term, formula-fed infants randomized to receive a partially hydrolyzed whey protein formula with and without probiotics for the first four months of life. It is hypothesized that there will be no difference in growth between the two groups.

Detailed Description

Not provided

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

No data available

No data is available for this block.

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
control infant formula	Active Comparator	partially hydrolyzed whey infant formula	Other: Control infant formula
test infant formula	Experimental	partially hydrolyzed whey infant formula with probiotic	Other: Test infant formula

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Control infant formula	Other	partially hydrolyzed whey infant formula consumed ad libitum throughout study	control infant formula

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
growth	weight gain assessed monthly	4 months

Secondary Outcomes

Measure	Description	Time Frame
other growth	Length, head circumference will be measured at monthly visits	4 months
adverse events	all adverse events will be documented throughout the study

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy newborn infant
Full-term
Birth weight > 2500 and < 4500 g
14±3 days of age on enrollment
Exclusively formula-fed, singleton birth
Having obtained his/her legal representative's informed consent

Exclusion Criteria:

Known or suspected cow-milk allergy
Congenital illness or malformation that may affect infant feeding and/or growth
Significant prenatal and/or postnatal disease
Any readmission to hospital prior to enrollment
Receiving prescription medication or frequent use of over the counter medications except vitamin and mineral supplements
Has received intravenous antibiotic therapy or oral probiotic in the last 7 days
Currently participating in another clinical study
Cannot be expected to comply with treatment

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

11 Days

Maximum Age

17 Days

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
North Scottsdale Pediatric Associates		Scottsdale	Arizona	85258	United States
Pediatrics & Adolescent Medicine