We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01081067
First Posted: March 5, 2010
Last Update Posted: January 5, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Mead Johnson Nutrition
  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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   1 Month to 18 Months   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Deolinda Scalabrin, M.D., Mead Johnson Nutrition
ClinicalTrials.gov Identifier: NCT01081067     History of Changes
Other Study ID Numbers: 3377-1 (6008)
First Submitted: March 3, 2010
First Posted: March 5, 2010
Last Update Posted: January 5, 2011
Last Verified: January 2011