Addition of Lactobacillus to Metronidazole in Treatment of CDAD

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2008-08-01

Study Completion Date

2010-07-31

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.

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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.

Conditions

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Enterocolitis Pseudomembranous Colitis Antibiotic-associated Colitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Arm 1

This are will not receive Lactobacillus

Group Type NO_INTERVENTION

No interventions assigned to this group

Arm 2

This arm will receive lactobacillus

Group Type EXPERIMENTAL

Lactobacillus GG

Intervention Type DRUG

This arm will receive the additional probiotic of lactobacillus GG

Interventions

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Lactobacillus GG

This arm will receive the additional probiotic of lactobacillus GG

Intervention Type DRUG

Other Intervention Names

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Lactobacillus

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No