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

Not Applicable

Completed

• Conditions: Gastrointestinal Problems
• Interventions: Other: Nutritional vanilla flavored beverage - 1) Milk-based beverage containing prebiotics 2) Milk-based beverage containing no prebiotics

• Registration Number: NCT01177605
• Lead Sponsor: Mead Johnson Nutrition

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-09
• Primary Completion: 2007-03
• Study First Submitted: 2010-08-03
• Study First Submitted QC: 2010-08-06
• Study First Posted: 2010-08-09
• Status Verified: 2011-08
• Last Update Submitted: 2011-08-31
• Last Update Posted: 2011-09-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Vanilla flavored milk-based beverage containing prebiotics	Nutritional vanilla flavored beverage - 1) Milk-based beverage containing prebiotics 2) Milk-based beverage containing no prebiotics	Vanilla flavored milk-based beverage containing prebiotics
Vanilla flavored milk-based beverage containing no prebiotics	Nutritional vanilla flavored beverage - 1) Milk-based beverage containing prebiotics 2) Milk-based beverage containing no prebiotics	Vanilla flavored milk-based beverage containing no prebiotics

Trial Locations

Locations (1)

Federal University of Bahia School of Medicine; 🇧🇷 Salvador, Bahia, Brazil