Addition of Lactobacillus to Metronidazole in Treatment of CDAD

United States Department of Veterans Affairs

Status and phase

Withdrawn

Phase 4

Conditions

Antibiotic-associated Colitis

Pseudomembranous Colitis

Enterocolitis

Treatments

Drug: Lactobacillus GG

Study type

Interventional

Funder types

Other

Other U.S. Federal agency

Identifiers

NCT00304863

H-17937

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.