Clinical Trial: Addition of Lactobacillus to Metronidazole in Treatment of CDAD
Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional
Official Title: Addition of a Probiotic (Lactobacillus GG) to Metronidazole for the Treatment of Clostridium Difficile Associated Disease
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 Summary: 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.
Sponsor: VA Medical Center, Houston
Current Primary Outcome:
- Response to Treatment [ Time Frame: less than 10 days ]the time to resolution of diarrhea caused by diarrhea
- Stool sample C. diff toxin assay [ Time Frame: 30 days after start of medication ]presence of C. diff toxin in stool after 30 days
Original Primary Outcome:
- Response to Treatment
- Stool sample C. diff toxin assay
Current Secondary Outcome:
Original Secondary Outcome:
Information By: VA Medical Center, Houston
Dates:
Date Received: March 16, 2006
Date Started: August 1, 2008
Date Completion: July 31, 2010
Last Updated: May 9, 2017
Last Verified: May 2017
