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

Acute Respiratory Infection Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01431469
• Other study ID #: 6001
• Status: Completed
• Phase: N/A
• First received: August 31, 2011
• Last updated: December 5, 2012
• Start date: September 2011
• Est. completion date: May 2012

Study information

• Verified date: December 2012
• Source: Mead Johnson Nutrition
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: HUPES Complex Ethics Committee (CEP)
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 12 Months to 48 Months

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Acute Respiratory Infection
• Diarrheal Disease
• Respiratory Tract Infections

Intervention

Dietary Supplement:
• Cow's milk
Powdered Whole Cow's Milk
• Follow-On Formula
Powdered Follow-On Formula with added long-chain Polyunsaturated fatty acid, prebiotics, and polysaccharide

Locations

Country	Name	City	State
Brazil	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

Sponsors (2)

Lead Sponsor	Collaborator
Mead Johnson Nutrition	Federal University of Bahia

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Episodes of acute respiratory infections and diarrheal disease		28 weeks	No
Secondary	Occurrence of allergic manifestations		28 weeks	No
Secondary	Systemic antibiotic use		28 weeks	No
Secondary	Duration of acute respiratory infection and diarrheal disease		28 weeks	No
Secondary	Changes in stool patterns		28 weeks	No
Secondary	Fecal and serum immune markers		28 weeks	No
Secondary	Serum Ferritin and Zinc status		28 weeks	No
Secondary	Incidence of stool parasites		28 weeks	No
Secondary	Growth		28 weeks	No
Secondary	Incidence of adverse events	The incidence of any adverse event for each participant	28 weeks	No
Secondary	Acceptance of study product	Acceptance of study product based on quantity consumed	28 weeks	No