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Fecal Bacterial Flora in Clostridium Difficile-Associated Diarrhea

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00304876
First Posted: March 20, 2006
Last Update Posted: September 10, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Baylor College of Medicine
Information provided by:
VA Medical Center, Houston
  Purpose
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.

Condition
Enterocolitis Pseudomembranous Colitis Antibiotic-Associated Colitis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Fecal Bacterial Flora in Clostridium Difficile-Associated Diarrhea

Resource links provided by NLM:


Further study details as provided by VA Medical Center, Houston:

Enrollment: 5
Study Start Date: October 2005
Study Completion Date: January 2007
Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients positive for C. difficile
Criteria

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:

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00304876


Locations
United States, Maryland
Johns Hopkins Medical Research Institute
Baltimore, Maryland, United States, 21205
United States, Texas
Michael E. DeBakey Veterans Affairs Medical Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
VA Medical Center, Houston
Baylor College of Medicine
Investigators
Principal Investigator: Daniel M Musher, M.D. Baylor College of Medicine, Houston VA Medical Center
  More Information

Responsible Party: Daniel Musher, MD, VAHouston
ClinicalTrials.gov Identifier: NCT00304876     History of Changes
Other Study ID Numbers: H-18158
First Submitted: March 16, 2006
First Posted: March 20, 2006
Last Update Posted: September 10, 2010
Last Verified: September 2010

Keywords provided by VA Medical Center, Houston:
Clostridium difficile associated diarrhea

Additional relevant MeSH terms:
Colitis
Diarrhea
Enterocolitis
Enterocolitis, Pseudomembranous
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Signs and Symptoms, Digestive
Signs and Symptoms
Clostridium Infections
Gram-Positive Bacterial Infections
Bacterial Infections