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Withdrawn

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00304863

Enrollment

Registered

2006-03-20

Start date

2008-08-01

Completion date

2010-07-31

Last updated

2017-05-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Antibiotic-associated Colitis, Enterocolitis, Pseudomembranous Colitis

Keywords

CDAD, Clostridium difficile Associated Diarrhea

Brief 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.

Interventions

DRUGLactobacillus GG

This arm will receive the additional probiotic of lactobacillus GG

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
Response to Treatment	less than 10 days	the time to resolution of diarrhea caused by diarrhea
Stool sample C. diff toxin assay	30 days after start of medication	presence of C. diff toxin in stool after 30 days

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026