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The assistant who was going to do this study moved to a different med center
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| Name | Class |
|---|---|
| Baylor College of Medicine | OTHER |
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | No Intervention | This are will not receive Lactobacillus | |
| Arm 2 | Experimental | This arm will receive lactobacillus |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lactobacillus GG | Drug | This arm will receive the additional probiotic of lactobacillus GG |
|
| Measure | Description | Time Frame |
|---|---|---|
| Response to Treatment | the time to resolution of diarrhea caused by diarrhea | less than 10 days |
| Stool sample C. diff toxin assay | presence of C. diff toxin in stool after 30 days | 30 days after start of medication |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel M Musher, M.D. | Baylor College of Medicine, Houston VA Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Michael E. DeBakey Veterans Affairs Medical Center | Houston | Texas | 77030 | United States |
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| ID | Term |
|---|---|
| D004760 | Enterocolitis |
| D004761 | Enterocolitis, Pseudomembranous |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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| ID | Term |
|---|---|
| C100843 | Lacteol |
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| D003015 | Clostridium Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |