NCT00760851|CompletedPhase 3DMC
Yogurt Study in Children 2-4 Years Old Attending Daycare
SIPPY II
Study to Investigate the Potential of Probiotics II
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Sponsor study identifier
Secondary identifiers
NIH
interventional
190
1 country
1
Study Start
September 2008
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
July 2009
Actual (reported)Study Completion
July 2010
Actual (reported)The purpose of this study is to determine the effectiveness of probiotics (popularly referred to as 'live active culture' or 'good bacteria') in preventing illnesses and consequent absences from school/daycare centers of children two to four years old that attend daycare at least 3 days per week. Two yogurt drinks will be administered, one containing a specific strain of probiotic, Bb-12. It is hypothesized that children receiving the Bb-12 drink will experience fewer illnesses and absences from daycare. In this study, participants will be asked to:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 2010
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 2008
Date type not reportedThis date has not been verified as actual or estimated.
September 24, 2008
Actual (reported)September 26, 2008
Actual (reported)July 2009
Actual (reported)July 2010
Actual (reported)To determine if consumption of a yogurt drink containing Bb-12 decreases the number of absences children have from daycare/school due to illness
90 days
Determine if the yogurt supplemented with Bb-12 results in overall improved parental satisfaction due to decreased illnesses in children attending daycare/school
90
Bb-12 supplemented strawberry yogurt drink
Regular strawberry yogurt drink with no Bb-12 added
10\^9 CFU Bb-12 per 4 oz yogurt
yogurt identical to intervention yogurt, only without Bb-12 added.
Georgetown University Department of Family Medicine, Research Division
Washington D.C., District of Columbia, 20009, United States
Daniel Merenstein, MD
Georgetown University
First Submitted
September 24, 2008
First Posted
September 26, 2008
Study Start
September 2008
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
July 2009
Actual (reported)Study Comparing Rifaximin With Xifaxan 200 mg in Traveler's Diarrhea
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Study Completion
July 2010
Actual (reported)Last Updated
March 18, 2011
Record last verified: 2011-02
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Source: ClinicalTrials.gov.
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