Addition of Lactobacillus to Metronidazole in Treatment of CDAD
| Status: | Withdrawn |
|---|---|
| Conditions: | Colitis, Gastrointestinal |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 5/11/2017 |
| Start Date: | August 1, 2008 |
| End Date: | July 31, 2010 |
Addition of a Probiotic (Lactobacillus GG) to Metronidazole for the Treatment of Clostridium Difficile Associated Disease
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.
GG will reduce the rate of failure or relapse following treatment of CDAD with
metronidazole.
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.
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.
Inclusion Criteria:
- Subjects will be identified based on the diagnosis of CDAD. This diagnosis is made
bases on the presence of diarrhea, fever, abdominal pain and/or leukocytosis together
with a positive fecal assay for Clostridium difficile toxin
Exclusion Criteria:
- Patients who are unable to take oral medications and those with underlying
gastrointestinal disease or colonostomy will be excluded.
- Patients currently taking penicillins, cephalosporins, quinolones or tetracyclines
will be excluded because these drugs are active against Lactobacillus.
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