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Completed

NCT Number: NCT00304876

Fecal Bacterial Flora in Clostridium Difficile-Associated Diarrhea

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.

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Key information

Conditions

Enterocolitis Antibiotic-Associated Colitis Bacterial Infections Bacterial Infections and Mycoses Clostridium Infections Digestive System Diseases Enterocolitis, Pseudomembranous Gastroenteritis Gastrointestinal Diseases Gram-Positive Bacterial Infections Infections Intestinal Diseases Pseudomembranous Colitis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Johns Hopkins Medical Research Institute, Baltimore, Maryland, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Sponsors and collaborators

Lead sponsor

Michael E. DeBakey VA Medical Center

Fed

Collaborators

  • Baylor College of Medicine

Registry information

Important dates

Study start
2005
Primary completion
2007
Study completion
2007
First posted
Mar 20, 2006
Registry last updated
Sep 10, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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