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

This study has been completed.
Sponsor:
Information provided by:
Mead Johnson Nutrition
ClinicalTrials.gov Identifier:
NCT01081067
First received: March 3, 2010
Last updated: January 3, 2011
Last verified: January 2011
  Purpose

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


Condition
Stool Output

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Assessment of Efficiency and Safety of an Infant Formula Containing a Probiotic in Children

Resource links provided by NLM:


Further study details as provided by Mead Johnson Nutrition:

Estimated Enrollment: 134
Study Start Date: October 2007
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
Control
Routine cow milk-based infant formula
Investigational
Cow milk-based infant formula containing probiotics

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   1 Month to 18 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)]

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01081067

Locations
Brazil
Metabolic Unit Fima Lifshitz, Federal University of Bahia School of Medicine
Salvador, Bahia, Brazil, 40110-170
Sponsors and Collaborators
Mead Johnson Nutrition
Investigators
Principal Investigator: Hugo Ribeiro, Jr., M.D. Professor Edgard Santos University Hospital - UFBA
  More Information

No publications provided

Responsible Party: Deolinda Scalabrin, M.D., Mead Johnson Nutrition
ClinicalTrials.gov Identifier: NCT01081067     History of Changes
Other Study ID Numbers: 3377-1 (6008)
Study First Received: March 3, 2010
Last Updated: January 3, 2011
Health Authority: Brazil: National Research Ethics Commission - CONEP

ClinicalTrials.gov processed this record on April 17, 2014