Addition of Lactobacillus to Metronidazole in Treatment of CDAD

Phase 4

Withdrawn

• Conditions: Enterocolitis; Pseudomembranous Colitis; Antibiotic-associated Colitis
• Interventions: Drug: Lactobacillus GG

• Registration Number: NCT00304863
• Lead Sponsor: Michael E. DeBakey VA Medical Center

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.

Study Timeline

• Study First Submitted: 2006-03-16
• Study First Submitted QC: 2006-03-16
• Study First Posted: 2006-03-20
• Study Start: 2008-08-01
• Primary Completion: 2010-07-31
• Study Completion: 2010-07-31
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-09
• Last Update Posted: 2017-05-10

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm 2	Lactobacillus GG	This arm will receive lactobacillus

Primary Outcome Measures

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

Trial Locations

Locations (1)

Michael E. DeBakey Veterans Affairs Medical Center; 🇺🇸 Houston, Texas, United States