Efficacy and Tolerance of a Follow-On Formula Fed to Children From 12-48 Months of Age in Salvador, Bahia, Brazil

Not Applicable

Completed

• Conditions: Acute Respiratory Infection; Diarrheal Disease
• Interventions: Dietary Supplement: Cow's milk; Dietary Supplement: Follow-On Formula

• Registration Number: NCT01431469
• Lead Sponsor: Mead Johnson Nutrition

Brief Summary

The purpose is to determine if the consumption of study product has an effect on acute respiratory infections and/or diarrheal disease.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-08-31
• Study Start: 2011-09
• Study First Submitted QC: 2011-09-08
• Study First Posted: 2011-09-09
• Primary Completion: 2012-05
• Study Completion: 2012-05
• Status Verified: 2012-12
• Last Update Submitted: 2012-12-05
• Last Update Posted: 2012-12-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 250

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cow's Milk	Cow's milk	Powdered Whole Cow's Milk
Follow-On Formula	Follow-On Formula	Powdered Follow-On Formula with added long-chain Polyunsaturated fatty acid, prebiotics, and polysaccharide

Primary Outcome Measures

Name	Time	Method
Episodes of acute respiratory infections and diarrheal disease	28 weeks

Secondary Outcome Measures

Name	Time	Method
Occurrence of allergic manifestations	28 weeks
Systemic antibiotic use	28 weeks
Duration of acute respiratory infection and diarrheal disease	28 weeks
Changes in stool patterns	28 weeks
Fecal and serum immune markers	28 weeks
Serum Ferritin and Zinc status	28 weeks
Incidence of stool parasites	28 weeks
Growth	28 weeks
Incidence of adverse events	28 weeks	The incidence of any adverse event for each participant
Acceptance of study product	28 weeks	Acceptance of study product based on quantity consumed

Trial Locations

Locations (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, Bahia, Brazil