NCT00760851

Yogurt Study in Children 2-4 Years Old Attending Daycare

Study to Investigate the Potential of Probiotics II

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 190 (estimated)
• Sponsor: Georgetown University · Academic / Other
• Sex: All
• Age: 2 Years – 4 Years
• Healthy volunteers: Accepted

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

Conditions

• Infections, Respiratory
• Diarrhea

Interventions

Type	Name	Description
OTHER	probiotic strain Bb-12	10\^9 CFU Bb-12 per 4 oz yogurt
OTHER	no Bb-12	yogurt identical to intervention yogurt, only without Bb-12 added.

Timeline

• Start date: 2008-09-01
• Primary completion: 2009-07-01
• Completion: 2010-07-01
• First posted: 2008-09-26
• Last updated: 2011-03-18

Locations

1 site across 1 country: United States