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OpenTrials
Completed

NCT Number: NCT01177605

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

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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Key information

Conditions

Gastrointestinal Problems

Age range

9 month–48 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Federal University of Bahia School of Medicine

Salvador, Estado de Bahia, 41830-380, Brazil

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Nutritional vanilla flavored beverage - 1) Milk-based beverage containing prebiotics 2) Milk-based beverage containing no prebiotics

Other

Nutritional vanilla flavored beverage - 1) Milk-based beverage containing prebiotics 2) Milk-based beverage containing no prebiotics

Sponsors and collaborators

Lead sponsor

Mead Johnson Nutrition

Industry

Registry information

Important dates

Study start
2006
Primary completion
2007
First posted
Aug 9, 2010
Registry last updated
Sep 2, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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