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Fecal Bacterial Flora in Clostridium Difficile-Associated Diarrhea

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ClinicalTrials.gov Identifier: NCT00304876
Recruitment Status : Completed
First Posted : March 20, 2006
Last Update Posted : September 10, 2010
Sponsor:
Collaborator:
Baylor College of Medicine
Information provided by:
VA Medical Center, Houston

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.

Condition or disease
Enterocolitis Pseudomembranous Colitis Antibiotic-Associated Colitis

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 Type : Observational
Actual Enrollment : 5 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Fecal Bacterial Flora in Clostridium Difficile-Associated Diarrhea
Study Start Date : October 2005
Actual Primary Completion Date : January 2007
Actual Study Completion Date : January 2007

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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:


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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

Responsible Party: Daniel Musher, MD, VAHouston
ClinicalTrials.gov Identifier: NCT00304876     History of Changes
Other Study ID Numbers: H-18158
First Posted: March 20, 2006    Key Record Dates
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