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

Gastrointestinal Problems Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01177605
• Other study ID #: 3376-1 (8575)
• Status: Completed
• Phase: N/A
• First received: August 3, 2010
• Last updated: August 31, 2011
• Start date: September 2006

Study information

• Verified date: August 2011
• Source: Mead Johnson Nutrition
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethical Research Committee of Complexo Hospitalar Universitário Edgar SantosBrazil: Research Ethics Committee of the Maternidade Climério de Oliveira - UFBA
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. primary completion date: March 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 9 Months to 48 Months

Eligibility

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

N/A

Related Conditions & MeSH terms

• Gastrointestinal Problems

Intervention

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

Locations

Country	Name	City	State
Brazil	Federal University of Bahia School of Medicine	Salvador	Bahia

Sponsors (1)

Lead Sponsor	Collaborator
Mead Johnson Nutrition

Country where clinical trial is conducted

Brazil,