Ignite Creation Date:
2025-12-24 @ 11:39 PM
Ignite Modification Date:
2025-12-28 @ 6:50 AM
Study NCT ID:
NCT00760851
Status:
COMPLETED
Last Update Posted:
2011-03-18
First Post:
2008-09-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Yogurt Study in Children 2-4 Years Old Attending Daycare
Sponsor:
Georgetown University
Organization:
Study Overview
Official Title:
Study to Investigate the Potential of Probiotics II
Status:
COMPLETED
Status Verified Date:
2011-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SIPPY II
Brief 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: