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| Tracking Information | |||||||||
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| First Received Date † | March 16, 2006 | ||||||||
| Last Updated Date | March 16, 2006 | ||||||||
| Start Date † | |||||||||
| Current Primary Outcome Measures † | |||||||||
| Original Primary Outcome Measures † | |||||||||
| Change History | No Changes Posted | ||||||||
| Current Secondary Outcome Measures † | |||||||||
| Original Secondary Outcome Measures † | |||||||||
| Descriptive Information | |||||||||
| Brief Title † | Fecal Bacterial Flora in Clostridium Difficile-Associated Diarrhea | ||||||||
| Official Title † | Fecal Bacterial Flora in Clostridium Difficile-Associated Diarrhea | ||||||||
| Brief Summary | 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. |
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| 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. |
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| Study Phase | |||||||||
| Study Type † | Observational | ||||||||
| Study Design † | Cross-Sectional, Defined Population, Retrospective Study | ||||||||
| Condition † |
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| Intervention † | |||||||||
| Study Arms / Comparison Groups | |||||||||
| Publications * | |||||||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status † | Recruiting | ||||||||
| Enrollment † | 80 | ||||||||
| Completion Date | |||||||||
| Primary Completion Date | |||||||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts †† |
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| Location Countries † | United States | ||||||||
| Expanded Access Status | |||||||||
| Administrative Information | |||||||||
| NCT ID † | NCT00304876 | ||||||||
| Responsible Party | |||||||||
| Secondary IDs †† | |||||||||
| Study Sponsor † | VA Medical Center, Houston | ||||||||
| Collaborators †† | Baylor College of Medicine | ||||||||
| Investigators † |
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| Information Provided By | VA Medical Center, Houston | ||||||||
| Verification Date | October 2005 | ||||||||
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† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |
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