Status:
WITHDRAWN
Addition of Lactobacillus to Metronidazole in Treatment of CDAD
Lead Sponsor:
Michael E. DeBakey VA Medical Center
Collaborating Sponsors:
Baylor College of Medicine
Conditions:
Enterocolitis
Pseudomembranous Colitis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 m...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 31 2010
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00304863
Start Date
August 1 2008
End Date
July 31 2010
Last Update
May 10 2017
Active Locations (1)
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1
Michael E. DeBakey Veterans Affairs Medical Center
Houston, Texas, United States, 77030