Fecal Bacterial Flora in Clostridium Difficile-Associated Diarrhea

This study has been completed.

First Received on March 16, 2006. Last Updated on September 9, 2010 History of Changes

Sponsor:	VA Medical Center, Houston
Collaborator:	Baylor College of Medicine
Information provided by:	VA Medical Center, Houston
ClinicalTrials.gov Identifier:	NCT00304876

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:

MedlinePlus related topics: Bowel Movement Diarrhea

U.S. FDA Resources

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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:

none

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party:	Daniel Musher, MD, VAHouston
ClinicalTrials.gov Identifier:	NCT00304876 History of Changes
Other Study ID Numbers:	H-18158
Study First Received:	March 16, 2006
Last Updated:	September 9, 2010
Health Authority:	United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on February 09, 2012