Assessment of Efficacy and Tolerance of a Follow-On Milk Containing a Mixture of Prebiotics Fed to Young Children in Salvador, Bahia, Brazil

This study has been completed.
Sponsor:
Information provided by:
Mead Johnson Nutrition
ClinicalTrials.gov Identifier:
NCT01177605
First received: August 3, 2010
Last updated: August 31, 2011
Last verified: August 2011
  Purpose

This clinical study will evaluate the effect on incidence of diarrhea, respiratory illness, stool patterns and growth of two cow's milk-based beverages for children.


Condition Intervention
Gastrointestinal Problems
Other: Nutritional vanilla flavored beverage - 1) Milk-based beverage containing prebiotics 2) Milk-based beverage containing no prebiotics

Study Type: Interventional

Further study details as provided by Mead Johnson Nutrition:

Study Start Date: September 2006
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Vanilla flavored milk-based beverage containing no prebiotics
Vanilla flavored milk-based beverage containing no prebiotics
Other: Nutritional vanilla flavored beverage - 1) Milk-based beverage containing prebiotics 2) Milk-based beverage containing no prebiotics
Nutritional vanilla flavored beverage - 1) Milk-based beverage containing prebiotics 2) Milk-based beverage containing no prebiotics
Experimental: Vanilla flavored milk-based beverage containing prebiotics
Vanilla flavored milk-based beverage containing prebiotics
Other: Nutritional vanilla flavored beverage - 1) Milk-based beverage containing prebiotics 2) Milk-based beverage containing no prebiotics
Nutritional vanilla flavored beverage - 1) Milk-based beverage containing prebiotics 2) Milk-based beverage containing no prebiotics

  Eligibility

Ages Eligible for Study:   9 Months to 48 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Child 9 - 48 months of age
  • Child has consumed a cow follow-on milk during the 48 hours prior to enrollment
  • Child's weight for age is within the 10th -90th percentiles
  • Child's length for age is within 10th - 90th percentiles
  • Signed informed consent obtained

Exclusion Criteria:

  • Children who are receiving predominantly breast-milk
  • Serious concurrent illness
  • Children with diarrhea or acute respiratory infection during the 48 hours prior to randomization
  • Children with a history of underlying metabolic or chronic disease or congenital malformation which, in the opinion of the Investigator, is likely to interfere with the normal growth and development or the evaluation of the participant.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01177605

Locations
Brazil
Federal University of Bahia School of Medicine
Salvador, Bahia, Brazil, 41830-380
Sponsors and Collaborators
Mead Johnson Nutrition
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT01177605     History of Changes
Other Study ID Numbers: 3376-1 (8575)
Study First Received: August 3, 2010
Last Updated: August 31, 2011
Health Authority: Brazil: Ethical Research Committee of Complexo Hospitalar Universitário Edgar Santos
Brazil: Research Ethics Committee of the Maternidade Climério de Oliveira - UFBA

ClinicalTrials.gov processed this record on April 22, 2014