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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01431469
Recruitment Status : Completed
First Posted : September 9, 2011
Last Update Posted : December 6, 2012
Sponsor:
Collaborator:
Federal University of Bahia
Information provided by (Responsible Party):
Mead Johnson Nutrition

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

Condition or disease Intervention/treatment Phase
Acute Respiratory Infection Diarrheal Disease Dietary Supplement: Cow's milk Dietary Supplement: Follow-On Formula Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Study Start Date : September 2011
Actual Primary Completion Date : May 2012
Actual Study Completion Date : May 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diarrhea

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Episodes of acute respiratory infections and diarrheal disease [ Time Frame: 28 weeks ]

Secondary Outcome Measures :
  1. Occurrence of allergic manifestations [ Time Frame: 28 weeks ]
  2. Systemic antibiotic use [ Time Frame: 28 weeks ]
  3. Duration of acute respiratory infection and diarrheal disease [ Time Frame: 28 weeks ]
  4. Changes in stool patterns [ Time Frame: 28 weeks ]
  5. Fecal and serum immune markers [ Time Frame: 28 weeks ]
  6. Serum Ferritin and Zinc status [ Time Frame: 28 weeks ]
  7. Incidence of stool parasites [ Time Frame: 28 weeks ]
  8. Growth [ Time Frame: 28 weeks ]
  9. Incidence of adverse events [ Time Frame: 28 weeks ]
    The incidence of any adverse event for each participant

  10. Acceptance of study product [ Time Frame: 28 weeks ]
    Acceptance of study product based on quantity consumed


Eligibility Criteria
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Ages Eligible for Study:   12 Months to 48 Months   (Child)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01431469


Locations
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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
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Mead Johnson Nutrition
ClinicalTrials.gov Identifier: NCT01431469    
Other Study ID Numbers: 6001
First Posted: September 9, 2011    Key Record Dates
Last Update Posted: December 6, 2012
Last Verified: December 2012
Additional relevant MeSH terms:
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Respiratory Tract Infections
Diarrhea
Infection
 Respiratory Tract Diseases
Signs and Symptoms, Digestive
Signs and Symptoms