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.

Study Overview

• Status: Completed
• Conditions: Gastrointestinal Problems
• Intervention / Treatment: Other: Nutritional vanilla flavored beverage - 1) Milk-based beverage containing prebiotics 2) Milk-based beverage containing no prebiotics

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Bahia
    • Salvador, Bahia, Brazil, 41830-380
      • Federal University of Bahia School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 9 months to 4 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: 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	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

Collaborators and Investigators

• Sponsor: Mead Johnson Nutrition

Study record dates

Study Major Dates

• Study Start: September 1, 2006
• Primary Completion (Actual): March 1, 2007

Study Registration Dates

• First Submitted: August 3, 2010
• First Submitted That Met QC Criteria: August 6, 2010
• First Posted (Estimate): August 9, 2010

Study Record Updates

• Last Update Posted (Estimate): September 2, 2011
• Last Update Submitted That Met QC Criteria: August 31, 2011
• Last Verified: August 1, 2011

More Information

Terms related to this study

• Other Study ID Numbers: 3376-1 (8575)