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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Infection
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on August 27, 2014