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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:
ClinicalTrials.gov Identifier:
NCT01177605
First Posted: August 9, 2010
Last Update Posted: September 2, 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
August 3, 2010
August 9, 2010
September 2, 2011
September 2006
March 2007   (Final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT01177605 on ClinicalTrials.gov Archive Site
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Assessment of Efficacy and Tolerance of a Follow-On Milk Containing a Mixture of Prebiotics Fed to Young Children in Salvador, Bahia, Brazil
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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.
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Interventional
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Gastrointestinal Problems
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
  • Placebo Comparator: Vanilla flavored milk-based beverage containing no prebiotics
    Vanilla flavored milk-based beverage containing no prebiotics
    Intervention: Other: 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
    Intervention: Other: Nutritional vanilla flavored beverage - 1) Milk-based beverage containing prebiotics 2) Milk-based beverage containing no prebiotics
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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March 2007   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
9 Months to 48 Months   (Child)
Yes
Contact information is only displayed when the study is recruiting subjects
Brazil
 
 
NCT01177605
3376-1 (8575)
No
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Mead Johnson Nutrition
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Mead Johnson Nutrition
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP