A Phase 3 interventional study of probiotic strain Bb-12 and no Bb-12 in Infections, Respiratory and Diarrhea, sponsored by Georgetown University. Completed at 1 site in United States. Open to participants aged 2 Years to 4 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-03-18.
Sponsored by Georgetown University · Phase 3, Interventional, and Prevention
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:
1,052 studies on the registry are indexed under Respiratory Tract Infections; 147 are open to participants now.
This study's planned enrollment of 190 is close to the median of 196 across 715 interventional studies indexed under Respiratory Tract Infections.
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Of its 28 completed or terminated interventional studies of FDA-regulated products, 20 (71%) have results posted.
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Exclusion Criteria:
Bb-12 supplemented strawberry yogurt drink
Other: probiotic strain Bb-12
Regular strawberry yogurt drink with no Bb-12 added
Other: no Bb-12
10\^9 CFU Bb-12 per 4 oz yogurt
Also known as: Bifidobacterium lactis 12
yogurt identical to intervention yogurt, only without Bb-12 added.
To determine if consumption of a yogurt drink containing Bb-12 decreases the number of absences children have from daycare/school due to illness
Time frame: 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
Time frame: 90
This study is completed, as verified in Feb 2011. You cannot join it, but the record below documents what was studied.
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Respiratory Tract Infections →