Addition of Lactobacillus to Metronidazole in Treatment of CDAD

Pseudomembranous Colitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00304863
• Other study ID #: H-17937
• Status: Withdrawn
• Phase: Phase 4
• First received: March 16, 2006
• Last updated: May 9, 2017
• Start date: August 1, 2008
• Est. completion date: July 31, 2010

Study information

• Verified date: May 2017
• Source: VA Medical Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 31, 2010
• Est. primary completion date: July 31, 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Antibiotic-associated Colitis
• Colitis
• Enterocolitis
• Enterocolitis, Pseudomembranous
• Pseudomembranous Colitis

Intervention

Drug:
• Lactobacillus GG
This arm will receive the additional probiotic of lactobacillus GG

Locations

Country	Name	City	State
United States	Michael E. DeBakey Veterans Affairs Medical Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
VA Medical Center, Houston	Baylor College of Medicine

Country where clinical trial is conducted

United States, 

Outcome

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