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Sponsors and Collaborators: |
VA Medical Center, Houston Baylor College of Medicine |
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Information provided by: | VA Medical Center, Houston |
ClinicalTrials.gov Identifier: | NCT00304863 |
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.
Condition | Intervention | Phase |
---|---|---|
Enterocolitis Pseudomembranous Colitis Antibiotic-Associated Colitis |
Drug: Lactobacillus GG |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind, Placebo Control, Single Group Assignment, Efficacy Study |
Official Title: | Addition of a Probiotic (Lactobacillus GG) to Metronidazole for the Treatment of Clostridium Difficile Associated Disease |
Estimated Enrollment: | 70 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Texas | |
Michael E. DeBakey Veterans Affairs Medical Center | |
Houston, Texas, United States, 77030 |
Principal Investigator: | Daniel M Musher, M.D. | Baylor College of Medicine, Houston VA Medical Center |
Study ID Numbers: | H-17937 |
Study First Received: | March 16, 2006 |
Last Updated: | March 16, 2006 |
ClinicalTrials.gov Identifier: | NCT00304863 |
Health Authority: | United States: Institutional Review Board |
CDAD Clostridium difficile Associated Diarrhea |
Bacterial Infections Metronidazole Diarrhea Gastrointestinal Diseases Colonic Diseases Enterocolitis, Pseudomembranous Intestinal Diseases |
Enterocolitis Gram-Positive Bacterial Infections Digestive System Diseases Gastroenteritis Clostridium Infections Colitis |
Anti-Infective Agents Antiparasitic Agents Antiprotozoal Agents Radiation-Sensitizing Agents |
Therapeutic Uses Physiological Effects of Drugs Pharmacologic Actions |