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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 31, 2014