NCT00304863

Addition of Lactobacillus to Metronidazole in Treatment of CDAD

Addition of a Probiotic (Lactobacillus GG) to Metronidazole for the Treatment of Clostridium Difficile Associated Disease

• Status: Withdrawn
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Michael E. DeBakey VA Medical Center · Federal
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Enterocolitis
• Pseudomembranous Colitis
• Antibiotic-associated Colitis

Interventions

Type	Name	Description
DRUG	Lactobacillus GG	This arm will receive the additional probiotic of lactobacillus GG

Timeline

• Start date: 2008-08-01
• Primary completion: 2010-07-31
• Completion: 2010-07-31
• First posted: 2006-03-20
• Last updated: 2017-05-10

Locations

1 site across 1 country: United States