Addition of Lactobacillus to Metronidazole in Treatment of CDAD

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Enterocolitis, Pseudomembranous Colitis, Antibiotic-associated Colitis

Intervention / Treatment
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* Drug: Lactobacillus GG


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Arm 1<br>This are will not receive Lactobacillus | |
| Experimental: Arm 2<br>This arm will receive lactobacillus | Drug: Lactobacillus GG<br>* This arm will receive the additional probiotic of lactobacillus GG<br>* Other names: Lactobacillus;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CDAD, Clostridium difficile Associated Diarrhea