Fecal Bacterial Flora in Clostridium Difficile-Associated Diarrhea

This study is currently recruiting participants.

Verified by VA Medical Center, Houston, October 2005

Sponsors and Collaborators:	VA Medical Center, Houston Baylor College of Medicine
Information provided by:	VA Medical Center, Houston
ClinicalTrials.gov Identifier:	NCT00304876

Purpose

We 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

MedlinePlus related topics: Diarrhea

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cross-Sectional, Defined Population, Retrospective Study
Official Title:	Fecal Bacterial Flora in Clostridium Difficile-Associated Diarrhea

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

Estimated Enrollment:

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. We 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

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

Contacts

Contact: Daniel M Musher, M.D.	713-794-7384	dmusher@bcm.tmc.edu
Contact: Nancy L Logan	713-794-7384	njarrar@bcm.tmc.edu

Locations

United States, Maryland
Johns Hopkins Medical Research Institute	Recruiting
Baltimore, Maryland, United States, 21205
Contact: Cynthia L Sears, M.D. 410-614-0141 csears@jhmi.edu
Principal Investigator: Cynthia L Sears, M.D.
United States, Texas
Michael E. DeBakey Veterans Affairs Medical Center	Recruiting
Houston, Texas, United States, 77030
Contact: Daniel M Musher, M.D. 713-794-7384 dmusher@bcm.tmc.edu
Contact: Nancy L Logan, M.A. 713-794-7384 njarrar@bcm.tmc.edu
Principal Investigator: Daniel M Musher, M.D.

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

Study ID Numbers:	H-18158
Study First Received:	March 16, 2006
Last Updated:	March 16, 2006
ClinicalTrials.gov Identifier:	NCT00304876
Health Authority:	United States: Institutional Review Board

Keywords provided by VA Medical Center, Houston:

Clostridium difficile associated diarrhea

Study placed in the following topic categories:

Bacterial Infections
Diarrhea
Signs and Symptoms, Digestive
Gastrointestinal Diseases
Colonic Diseases
Enterocolitis, Pseudomembranous
Intestinal Diseases

Enterocolitis
Signs and Symptoms
Gram-Positive Bacterial Infections
Digestive System Diseases
Gastroenteritis
Clostridium Infections
Colitis

ClinicalTrials.gov processed this record on January 16, 2009