Fecal Bacterial Flora in Clostridium Difficile-Associated Diarrhea

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

5 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-10-31

Study Completion Date

2007-01-31

Brief Summary

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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

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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.

Conditions

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Enterocolitis Pseudomembranous Colitis Antibiotic-Associated Colitis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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VAHouston

Principal Investigators

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Daniel M Musher, M.D.

Role: PRINCIPAL_INVESTIGATOR

Baylor College of Medicine, Houston VA Medical Center

Locations

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Johns Hopkins Medical Research Institute

Baltimore, Maryland, United States

Site Status

Michael E. DeBakey Veterans Affairs Medical Center

Houston, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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H-18158

Identifier Type: -

Identifier Source: org_study_id