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Clinical Trial Summary

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


Clinical Trial Description

n/a


Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention


Related Conditions & MeSH terms


NCT number NCT00760851
Study type Interventional
Source Georgetown University
Contact
Status Completed
Phase Phase 3
Start date September 2008
Completion date July 2010

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