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Study to Investigate the Potential of Probiotics II (SIPPY II)
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. Give their child 4 oz. of the test yogurt each day for 90 days 2. Keep a daily diary of their child's health 3. Collect 3 stool samples from their child at the start, middle, and end of the study 4. Speak with research personnel on a bi-weekly basis regarding their child's health 5. Ensure that their child to consume any yogurts or probiotic-containing products for 110 days of the study
Details
| Lead sponsor | Georgetown University |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 190 |
| Start date | 2008-09 |
| Completion | 2010-07 |
Conditions
- Infections, Respiratory
- Diarrhea
Interventions
- probiotic strain Bb-12
- no Bb-12
Primary outcomes
- 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
Countries
United States