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

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

Study Overview

• Status: Completed
• Conditions: Acute Respiratory Infection; Diarrheal Disease
• Intervention / Treatment: Dietary supplement: Cow's milk; Dietary supplement: Follow-On Formula

• Study Type: Interventional
• Enrollment (Anticipated): 250
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Bahia
    • Salvador, Bahia, Brazil, CEP 401 10-060
      • 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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 4 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Cow's Milk; Powdered Whole Cow's Milk	Dietary supplement: Cow's milk; Powdered Whole Cow's Milk
Experimental: Follow-On Formula; Powdered Follow-On Formula with added long-chain Polyunsaturated fatty acid, prebiotics, and polysaccharide	Dietary supplement: Follow-On Formula; Powdered Follow-On Formula with added long-chain Polyunsaturated fatty acid, prebiotics, and polysaccharide

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Episodes of acute respiratory infections and diarrheal disease	28 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	The incidence of any adverse event for each participant	28 weeks
Acceptance of study product	Acceptance of study product based on quantity consumed	28 weeks

Collaborators and Investigators

• Sponsor: Mead Johnson Nutrition
• Collaborators: Federal University of Bahia

Publications and helpful links

General Publications

• Pontes MV, Ribeiro TC, Ribeiro H, de Mattos AP, Almeida IR, Leal VM, Cabral GN, Stolz S, Zhuang W, Scalabrin DM. Cow's milk-based beverage consumption in 1- to 4-year-olds and allergic manifestations: an RCT. Nutr J. 2016 Feb 27;15:19. doi: 10.1186/s12937-016-0138-0.

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (Actual): May 1, 2012
• Study Completion (Actual): May 1, 2012

Study Registration Dates

• First Submitted: August 31, 2011
• First Submitted That Met QC Criteria: September 8, 2011
• First Posted (Estimate): September 9, 2011

Study Record Updates

• Last Update Posted (Estimate): December 6, 2012
• Last Update Submitted That Met QC Criteria: December 5, 2012
• Last Verified: December 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Diseases; Respiratory Tract Infections
• Other Study ID Numbers: 6001