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

This study has been completed.
Sponsor:
Collaborator:
Federal University of Bahia
Information provided by (Responsible Party):
Mead Johnson Nutrition
ClinicalTrials.gov Identifier:
NCT01431469
First received: August 31, 2011
Last updated: December 5, 2012
Last verified: December 2012
History of Changes
  Purpose

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


Condition Intervention
Acute Respiratory Infection
Diarrheal Disease
 Dietary Supplement: Cow's milk
Dietary Supplement: Follow-On Formula

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

Further study details as provided by Mead Johnson Nutrition:

Primary Outcome Measures:
  • Episodes of acute respiratory infections and diarrheal disease [ Time Frame: 28 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Occurrence of allergic manifestations [ Time Frame: 28 weeks ] [ Designated as safety issue: No ]
  • Systemic antibiotic use [ Time Frame: 28 weeks ] [ Designated as safety issue: No ]
  • Duration of acute respiratory infection and diarrheal disease [ Time Frame: 28 weeks ] [ Designated as safety issue: No ]
  • Changes in stool patterns [ Time Frame: 28 weeks ] [ Designated as safety issue: No ]
  • Fecal and serum immune markers [ Time Frame: 28 weeks ] [ Designated as safety issue: No ]
  • Serum Ferritin and Zinc status [ Time Frame: 28 weeks ] [ Designated as safety issue: No ]
  • Incidence of stool parasites [ Time Frame: 28 weeks ] [ Designated as safety issue: No ]
  • Growth [ Time Frame: 28 weeks ] [ Designated as safety issue: No ]
  • Incidence of adverse events [ Time Frame: 28 weeks ] [ Designated as safety issue: No ]
    The incidence of any adverse event for each participant

  • Acceptance of study product [ Time Frame: 28 weeks ] [ Designated as safety issue: No ]
    Acceptance of study product based on quantity consumed


Estimated Enrollment: 250
Study Start Date: September 2011
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   12 Months to 48 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01431469

Locations
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, Brazil, CEP 401 10-060
Sponsors and Collaborators
Mead Johnson Nutrition
Federal University of Bahia
  More Information

No publications provided

Responsible Party: Mead Johnson Nutrition
ClinicalTrials.gov Identifier: NCT01431469     History of Changes
Other Study ID Numbers: 6001
Study First Received: August 31, 2011
Last Updated: December 5, 2012
Health Authority: Brazil: HUPES Complex Ethics Committee (CEP)

Additional relevant MeSH terms:
Respiratory Tract Infections
Diarrhea
Infection
 Respiratory Tract Diseases
Signs and Symptoms, Digestive
Signs and Symptoms

ClinicalTrials.gov processed this record on June 18, 2013