Assessment of Efficiency and Safety of an Infant Formula Containing a Probiotic in Children
NCT ID: NCT01081067
Last Updated: 2011-01-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
134 participants
OBSERVATIONAL
2007-10-31
2010-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Control
Routine cow milk-based infant formula
No interventions assigned to this group
Investigational
Cow milk-based infant formula containing probiotics
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* acute diarrhea
* adequately hydrated
* signed informed consent
Exclusion Criteria
* bloody diarrhea
* intercurrent illnesses that may affect study parameters
* use of systemic antibiotics during the 72 hours prior to enrollment
* use of anti-diarrheal medications at the time of enrollment
* use of supplement or infant formula with Lactobacillus rhamnosus 10 days prior to enrollment
1 Month
18 Months
ALL
No
Sponsors
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Mead Johnson Nutrition
INDUSTRY
Responsible Party
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Mead Johnson Nutrition
Principal Investigators
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Hugo Ribeiro, Jr., M.D.
Role: PRINCIPAL_INVESTIGATOR
Professor Edgard Santos University Hospital - UFBA
Locations
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Metabolic Unit Fima Lifshitz, Federal University of Bahia School of Medicine
Salvador, Estado de Bahia, Brazil
Countries
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Other Identifiers
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3377-1 (6008)
Identifier Type: -
Identifier Source: org_study_id
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