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

NCT01177605 | Completed

• 1 other identifier: 3376-1 (8575)
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastrointestinal Problems

Study Arms (2)

Vanilla flavored milk-based beverage containing no prebiotics

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

Vanilla flavored milk-based beverage containing 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

Interventions

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

Vanilla flavored milk-based beverage containing no prebiotics; Vanilla flavored milk-based beverage containing prebiotics

Eligibility Criteria

• Age: 9 Months - 48 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mead Johnson Nutrition: lead

Study Sites (1)

Federal University of Bahia School of Medicine

Salvador, Estado de Bahia, 41830-380, Brazil

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 3, 2010
• First Posted: August 9, 2010
• Study Start: September 1, 2006
• Primary Completion: March 1, 2007
• Last Updated: September 2, 2011

Record last verified: 2011-08

Locations

BR (1)