Assessment of Efficiency and Safety of an Infant Formula... | NCT01081067

Studies
Assessment of Efficiency and Safety of an Infant Formula Containing a Probiotic in Children

NCT01081067

Sponsor

Mead Johnson Nutrition

Status

Completed

Last Update Posted

Jan 5, 2011Estimated

Enrollment

134Estimated

Phase

Not provided

Conditions

Stool Output

Interventions

Not provided

Countries

Brazil

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 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

Oct 2007

Primary Completion Date

Dec 2010Actual

Completion Date

Dec 2010Actual

First Submitted Date

Mar 3, 2010

First Submission Date that Met QC Criteria

Mar 3, 2010

First Posted Date

Mar 5, 2010Estimated

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

Jan 3, 2011

Last Update Posted Date

Jan 5, 2011Estimated

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

Evaluate the effect of probiotics on stool output in children 1 - 18 months old.

Detailed Description

Evaluate the effect of probiotics on stool output in children 1 - 18 months old.

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

134Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Control		Routine cow milk-based infant formula
Investigational		Cow milk-based infant formula containing probiotics

Interventions

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

children 1 - 18 months of age
acute diarrhea
adequately hydrated
signed informed consent

Exclusion Criteria:

exclusively or predominantly breast-feeding
bloody diarrhea
intercurrent illnesses that may affect study parameters
use of systemic antibiotics during the 72 hours prior to enrollment
use of anti-diarrheal medications at the time of enrollment
use of supplement or infant formula with Lactobacillus rhamnosus 10 days prior to enrollment

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Month

Maximum Age

18 Months

Standard Ages

Child

Study Population

CPPHO [Centro Pediátrico Professor Hosannah de Oliveira (Professor Hosannah de Oliveira Pediatirc Center] C-HUPES [Complexo Hospitalar Professor Edgar Santos (Professor Edgar Santos Hospital Complex)]

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Hugo Ribeiro, Jr., M.D.	Professor Edgard Santos University Hospital - UFBA	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Metabolic Unit Fima Lifshitz, Federal University of Bahia School of Medicine		Salvador	Estado de Bahia	40110-170	Brazil