Status:
COMPLETED
Efficacy and Tolerance of a Follow-On Formula Fed to Children From 12-48 Months of Age in Salvador, Bahia, Brazil
Lead Sponsor:
Mead Johnson Nutrition
Collaborating Sponsors:
Federal University of Bahia
Conditions:
Acute Respiratory Infection
Diarrheal Disease
Eligibility:
All Genders
12-48 years
Phase:
NA
Brief Summary
The purpose is to determine if the consumption of study product has an effect on acute respiratory infections and/or diarrheal disease.
Eligibility Criteria
Inclusion
- Child 12-48 months of age
- Has consumed cow's milk or a cow's milk-based beverage during the 48 hours prior to randomization
- Signed informed consent
Exclusion
- Child who is receiving predominantly breast-milk
- Child who received any food product or supplement containing probiotics or prebiotics in the 15 days prior to randomization
- Child with allergy to gluten or serious concurrent illness that will interfere in the general management of the child
- Child with diarrhea or acute respiratory infection during the 48 hours prior to randomization
- Child's z-score of weight for length/height \< -3 according to World Health Organization criteria
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2012
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT01431469
Start Date
September 1 2011
End Date
May 1 2012
Last Update
December 6 2012
Active Locations (1)
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1
Universidade Federal da Bahia, Hospital Universitário Prof. Edgard Santos Complexo HUPES, Centro Pediátrico Professor Hossanah Oliveira, Centro da Pesquisas Fima Lifshitz, Rua Augusto Viana s/n Canela
Salvador, Estado de Bahia, Brazil, CEP 401 10-060