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

January 3, 2011 updated by: Mead Johnson Nutrition
Evaluate the effect of probiotics on stool output in children 1 - 18 months old.

Study Overview

Status

Completed

Conditions

Detailed Description

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

Study Type

Observational

Enrollment (Anticipated)

134

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Bahia
      • Salvador, Bahia, Brazil, 40110-170
        • Metabolic Unit Fima Lifshitz, Federal University of Bahia School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 month to 1 year (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

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)]

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Control
Routine cow milk-based infant formula
Investigational
Cow milk-based infant formula containing probiotics

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mead Johnson Nutrition

Investigators

  • Principal Investigator: Hugo Ribeiro, Jr., M.D., Professor Edgard Santos University Hospital - UFBA

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2007

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

March 3, 2010

First Submitted That Met QC Criteria

March 3, 2010

First Posted (Estimate)

March 5, 2010

Study Record Updates

Last Update Posted (Estimate)

January 5, 2011

Last Update Submitted That Met QC Criteria

January 3, 2011

Last Verified

January 1, 2011

More Information

Terms related to this study

Other Study ID Numbers

  • 3377-1 (6008)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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