Addition of Lactobacillus to Metronidazole in Treatment of CDAD

Condition(s) targeted: Enterocolitis; Pseudomembranous Colitis; Antibiotic-Associated Colitis

Intervention: Lactobacillus GG (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: VA Medical Center, Houston

Official(s) and/or principal investigator(s):
Daniel M Musher, M.D., Principal Investigator, Affiliation: Baylor College of Medicine, Houston VA Medical Center

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.

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

Study design: Treatment, Randomized, Single Blind, Placebo Control, Single Group Assignment, Efficacy Study

Primary outcome:

Response to Treatment

Stool sample C. diff toxin assay

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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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.

Michael E. DeBakey Veterans Affairs Medical Center, Houston, Texas 77030, United States

Last updated: March 16, 2006