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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Gastrointestinal Problems

Study Groups

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Vanilla flavored milk-based beverage containing no prebiotics

Group Type PLACEBO_COMPARATOR

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

Intervention Type 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

Group Type EXPERIMENTAL

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

Intervention Type OTHER

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

Interventions

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

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

9 Months

Maximum Eligible Age

48 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes