Fecal Bacterial Flora in Clostridium Difficile-Associated Diarrhea

Pseudomembranous Colitis Clinical Trial

Official title:

Fecal Bacterial Flora in Clostridium Difficile-Associated Diarrhea

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00304876
• Other study ID #: H-18158
• Status: Completed
• Phase: N/A
• First received: March 16, 2006
• Last updated: September 9, 2010
• Start date: October 2005
• Est. completion date: January 2007

Study information

• Verified date: September 2010
• Source: VA Medical Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: January 2007
• Est. primary completion date: January 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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:

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Antibiotic-Associated Colitis
• Colitis
• Diarrhea
• Enterocolitis
• Enterocolitis, Pseudomembranous
• Pseudomembranous Colitis

Locations

Country	Name	City	State
United States	Johns Hopkins Medical Research Institute	Baltimore	Maryland
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,