CompletedNCT01177605Updated Sep 2, 2011

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

An interventional study of Nutritional vanilla flavored beverage - 1) Milk-based beverage containing prebiotics 2) Milk-based beverage containing no prebiotics in Gastrointestinal Problems, sponsored by Mead Johnson Nutrition. Completed at 1 site in Brazil. Open to participants aged 9 Months to 48 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-09-02.

Sponsored by Mead Johnson Nutrition (part of Reckitt) · Not applicable and Interventional

Phase: Not applicable
Study type: Interventional
Ages: 9 Months to 48 Months
Sex: All

Study 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 studied

Gastrointestinal Problems

In context

Lead sponsor

Mead Johnson Nutrition is the lead sponsor of 58 studies on the registry; 1 is open to participants now.

First submitted before Mead Johnson Nutrition became part of Reckitt.

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Who can participate

Ages eligible: 9 Months to 48 Months
Sexes eligible: All
Accepts healthy volunteers: Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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

Phase: Not applicable

Study arms

Placebo comparator
Vanilla flavored milk-based beverage containing no prebiotics
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
Experimental
Vanilla flavored milk-based beverage containing prebiotics
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

OtherNutritional 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

Study locations

1 site

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

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Sep 2, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01177605
Lead sponsor: Mead Johnson Nutrition
First posted: Aug 9, 2010
Start date: Sep 2006
Primary completion: Mar 2007
Last update: Sep 2, 2011

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2011. You cannot join it, but the record below documents what was studied.

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Discussion

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