Investigation of A Children's Beverage Containing Differe... | NCT00990002

Studies
Investigation of A Children's Beverage Containing Different Probiotics

NCT00990002

Sponsor

Mead Johnson Nutrition

Status

Completed

Last Update Posted

May 10, 2011Estimated

Enrollment

30Estimated

Phase

Not provided

Conditions

Immunity

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

May 2011

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

Sep 2009

Primary Completion Date

May 2011Actual

Completion Date

May 2011Actual

First Submitted Date

Oct 5, 2009

First Submission Date that Met QC Criteria

Oct 5, 2009

First Posted Date

Oct 6, 2009Estimated

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

May 9, 2011

Last Update Posted Date

May 10, 2011Estimated

Name	Class
Father Flanagan's Boys' Home	OTHER

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

Design Module

Study Type

Observational

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 provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Control		A children's milk-based beverage
experimental probiotic 1		children's milk-based beverage containing a bioactive ingredient
experimental probiotic 2		children's milk-based beverage containing a different bioactive ingredient

Interventions

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Children 2-4 years of age, weight and length for age within the 10th to 90th percentiles as plotted on the NCHS growth chart
Consuming cow's milk for at least one month

Exclusion Criteria:

Serious concurrent illness or acute infection
Using systemic antibiotics or steroids
Recent probiotic use
Feeding difficulties or intolerance to cow's milk
Conditions effecting normal growth and development
Immunodeficiencies

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

2 Years

Maximum Age

4 Years

Standard Ages

Child

Study Population

children 2-4 years of age

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Boys Town National Research Hospital		Boys Town	Nebraska	68010	United States