Addition of Lactobacillus to Metronidazole in Treatment of CDAD
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Purpose
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 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Single Blind Primary Purpose: Treatment |
| Official Title: | Addition of a Probiotic (Lactobacillus GG) to Metronidazole for the Treatment of Clostridium Difficile Associated Disease |
- Response to Treatment
- Stool sample C. diff toxin assay
| Estimated Enrollment: | 70 |
| Study Start Date: | January 2005 |
| Study Completion Date: | January 2007 |
| Primary Completion Date: | January 2007 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations| 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 |
More Information
No publications provided
| Responsible Party: | Daniel M. Musher MD, Principle Investigator, VA Medical Center, Houston |
| ClinicalTrials.gov Identifier: | NCT00304863 History of Changes |
| Other Study ID Numbers: | H-17937 |
| Study First Received: | March 16, 2006 |
| Last Updated: | February 14, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by VA Medical Center, Houston:
|
CDAD Clostridium difficile Associated Diarrhea |
Additional relevant MeSH terms:
|
Colitis Enterocolitis Enterocolitis, Pseudomembranous Gastroenteritis Gastrointestinal Diseases Digestive System Diseases Colonic Diseases Intestinal Diseases Clostridium Infections Gram-Positive Bacterial Infections |
Bacterial Infections Metronidazole Radiation-Sensitizing Agents Physiological Effects of Drugs Pharmacologic Actions Anti-Infective Agents Therapeutic Uses Antiprotozoal Agents Antiparasitic Agents |
ClinicalTrials.gov processed this record on June 18, 2013