Ignite Creation Date:
2024-05-05 @ 4:44 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00304863
Status:
WITHDRAWN
Last Update Posted:
2017-05-10
First Post:
2006-03-16
Brief Title:
Addition of Lactobacillus to Metronidazole in Treatment of CDAD
Sponsor:
Michael E DeBakey VA Medical Center
Organization:
Michael E DeBakey VA Medical Center
Study Overview
Official Title:
Addition of a Probiotic Lactobacillus GG to Metronidazole for the Treatment of Clostridium Difficile Associated Disease
Status:
WITHDRAWN
Status Verified Date:
2017-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The assistant who was going to do this study moved to a different med center
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine whether dietary supplementation with Lactobacillus GG will reduce the rate of failure or relapse following treatment of CDAD with metronidazole
Detailed Description:
Clostridium difficile associated disease CDAD which nearly always follows antibiotic therapy has become increasingly common and important in American hospitals causing substantial morbidity and mortality Metronidazole is the recommended treatment for this condition We have recently reported Clin Infect Dis June 2005 that treatment with metronidazole is associated with a 22 rate of failure and 28 rate of relapse No other medication has been shown to be more effective There is a substantial theory and some limited data to suggest that dietary supplementation with non-pathogenic normal bowel bacteria will benefit these patients Lactobacillus GG is the best-standardized and the most extensively studied of these agents
Study Oversight
Has Oversight DMC:
None
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?:
None