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

Mead Johnson Nutrition

Status: Completed

Conditions: Gastrointestinal Problems

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT01177605

3376-1 (8575)

Details and patient eligibility

About

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.

Sex: All

Ages: 9 to 48 months old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

0 participants in 2 patient groups, including a placebo group

Vanilla flavored milk-based beverage containing no prebiotics

Placebo Comparator group

Description:

Vanilla flavored milk-based beverage containing no prebiotics

Treatment:

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 group

Description:

Vanilla flavored milk-based beverage containing prebiotics

Treatment:

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