Unknown statusInterventionalNot ApplicableUpdated Dec 17, 2020
Efficacy and Tolerance of a Follow-On Formula Fed to Children From 12-48 Months of Age in Salvador, Bahia, Brazil | NCT01431469 | Trialant
CompletedInterventionalNot ApplicableUpdated Dec 6, 2012
Efficacy and Tolerance of a Follow-On Formula Fed to Children From 12-48 Months of Age in Salvador, Bahia, Brazil
ClinicalTrials.gov ID
NCT01431469
Lead Sponsor
Mead Johnson NutritionINDUSTRY
Overall Status
Completed
Study Type
Interventional
Phase
Not Applicable
Enrollment
250Estimated
Last Update Posted
Dec 6, 2012Estimated
Start Date
Sep 2011
Primary Completion Date
May 2012Actual
Completion Date
May 2012Actual
Brief Summary
The purpose is to determine if the consumption of study product has an effect on acute respiratory infections and/or diarrheal disease.
Acute Respiratory Infection
Diarrheal Disease
Cow's milk
Follow-On Formula
Ages Eligible for Study
Child (0-17)
Sexes Eligible for Study
All
Accepts Healthy Volunteers
Yes
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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
Primary Purpose
Prevention
Allocation
Randomized
Interventional Model
Parallel Assignment
Masking
Quadruple
No central contacts
There are no central contacts for this study.
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