Fecal Bacterial Flora in Clostridium Difficile-Associated Diarrhea

Completed

• Conditions: Enterocolitis; Antibiotic-Associated Colitis; Pseudomembranous Colitis

• Registration Number: NCT00304876
• Lead Sponsor: Michael E. DeBakey VA Medical Center

Brief Summary

The investigators propose to study intensively the bacteriology of feces in C. difficile associated diarrheal disease, using a variety of conventional and very up-to-date techniques.

Detailed Description

Clostridium difficile associated colitis is an increasing problem in hospitals throughout the developed world; the number of cases has increased, and the failure to respond to conventional therapy has become far more common. The investigators have recently documented in the medical literature (Clin Infect Dis, June, 2005; Lancet Infect Dis, August, 2005). Possible reasons for failure of treatment include persistence of C. difficile and/or imbalance of other bacterial flora in the colon. The bacteriology of fecal flora in C. difficile associated diarrhea has not been studied.

Study Timeline

• Study Start: 2005-10
• Study First Submitted: 2006-03-16
• Study First Submitted QC: 2006-03-16
• Study First Posted: 2006-03-20
• Primary Completion: 2007-01
• Study Completion: 2007-01
• Status Verified: 2010-09
• Last Update Submitted: 2010-09-09
• Last Update Posted: 2010-09-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5

Inclusion Criteria

• Patients with antibiotic-associated diarrhea with a positive assay for C. difficile toxin
• Patients with antibiotic-associated diarrhea with 3 negative assays for C. difficile toxin
• Patients with antibiotic-associated diarrhea that has failed to respond to conventional therapy
• Hospitalized patients who have received >2 antibiotics and who have no symptoms of diarrhea or abdominal discomfort

Exclusion Criteria

• none

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (2)

Johns Hopkins Medical Research Institute; 🇺🇸 Baltimore, Maryland, United States

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