Pathogenic Mechanisms in C Diff Infection and Colitis
Completed
Conditions studied: Clostridium Difficile Infection
In brief
The purpose of this study is to learn more about infection by Clostridium difficile (also known as C. difficile). C. difficile is a common bacterium (a germ that may cause disease) that can live in the human gut. Some people have it without having any symptoms. In other people it can cause illness ranging from mild diarrhea to severe colitis (infection of the colon). C. difficile makes toxins that damage the cells that line the colon. The study doctors want to find out how these toxins cause damage to the cells in the colon.
Key facts
- Study ID
- NCT01930032
- Run by
- Beth Israel Deaconess Medical Center
- People needed
- 24
- Starts
- 2013-08-01
- Expected to finish
- 2014-01-01
- Last updated by the study team
- 2017-03-08
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Age greater than 18 yrs and less than 75 years
- Undergoing a clinically indicated colonoscopy
You may not qualify if…
- Known, active or recurrent colonic disease including: Clostridium difficile infection, inflammatory bowel disease, microscopic colitis, colon resection for any reason, ischemic colitis, recurrent diverticulitis, colon cancer. Note: Diverticulosis without recurrent diverticulitis, colonic adenomatous or hyperplastic polyps or colonic arteriovenous malformations will not constitute an exclusion
- Diarrhea (an average of more than 3 bowel movements per day at baseline)
- Constipation (an average of fewer than 2 bowel movements per week at baseline).
- Use of systemic steroid or systemic immunosuppressive medication
- Severe renal impairment
- Relative contraindication to colon biopsy including a bleeding diathesis or anti-coagulant use. Note: nonsteroidal antiinflammatory drug or asprin use will not constitute a contra-indication.
Where it is running
- Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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