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Clinical Trial 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.


Clinical Trial 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 Design


Related Conditions & MeSH terms


NCT number NCT00304863
Study type Interventional
Source VA Medical Center, Houston
Contact
Status Withdrawn
Phase Phase 4
Start date August 1, 2008
Completion date July 31, 2010

See also
  Status Clinical Trial Phase
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Completed NCT00304876 - Fecal Bacterial Flora in Clostridium Difficile-Associated Diarrhea N/A
Completed NCT03427229 - Fecal Microbiota Transplantation for Severe Clostridium Difficile Infection Phase 2
Completed NCT00106509 - A Study of GT267-004 Versus Vancomycin and GT267-004 Versus Metronidazole in Patients With C.Difficile - Associated Diarrhea Phase 3
Completed NCT00304369 - Response of Clostridium Difficile Infection to Metronidazole Therapy N/A
Completed NCT00304889 - Vancomycin vs. Nitazoxanide to Treat Recurrent C. Difficile Colitis Phase 3
Completed NCT00304408 - Association Between Response to Treatment of C. Diff Colitis and Anti-C.Diff Toxin Antibody Phase 4
Completed NCT00304356 - Compassionate Use of Nitazoxanide for the Treatment of Clostridium Difficile Infection Phase 3
Completed NCT00182429 - Efficacy of Metronidazole Versus Metronidazole and Rifampin in CDAD Treatment Phase 3