Pathogenic Mechanisms in C Diff Infection and Colitis
Pathogenic Mechanisms in Clostridium Difficile Infection and Colitis
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.
研究概览
地位
条件
详细说明
The purpose of this study is to examine pathogenic mechanisms of Clostridium difficile toxin-mediated intestinal injury and inflammation. Two primary mechanisms will be examined.
- To examine the hypothesis is that microRNA expression profiles are dysregulated by Clostridium difficile toxin exposure and that dysregulation of miRNA expression plays a role in the pathogenesis of C. difficile associated diseases.
- To examine the hypothesis is that the TLR9 receptor mediates key inflammatory events in response to Clostridium difficile toxin exposure.
研究类型
注册 (实际的)
联系人和位置
学习地点
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Massachusetts
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Boston、Massachusetts、美国、02215
- Beth Israel Deaconess Medical Center
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- Age greater than 18 yrs and less than 75 years
- Undergoing a clinically indicated colonoscopy
Exclusion Criteria:
- 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.
学习计划
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
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所有科目
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Binding of Toxin A (and B) to TLR9 on the human colorectal epithelial cell surface
大体时间：24 hours
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As assessed by confocal fluorescence microscopy
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24 hours
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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effects of a TLR9 antagonist (ODN-TTAGGG) on toxin binding
大体时间：0 hours
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The change of mean toxin fluorescence on colonocytes will be measured by confocal microscopy using quantitative image analysis software.
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0 hours
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Binding of Toxin A (and B) to TLR9 on the human colorectal epithelial cell surface
大体时间：0 hours
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as assessed by confocal fluorescence microscopy
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0 hours
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Binding of Toxin A (and B) to TLR9 on the human colorectal epithelial cell surface
大体时间：6 hours
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As assessed by confocal fluorescence microscopy
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6 hours
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Effects of a TLR9 antagonist (ODN-TTAGGG) on toxin binding
大体时间：6 hours
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The change of mean toxin fluorescence on colonocytes will be measured by confocal microscopy using quantitative image analysis software.
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6 hours
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Effects of a TLR9 antagonist (ODN-TTAGGG) on toxin binding
大体时间：24 hours
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The change of mean toxin fluorescence on colonocytes will be measured by confocal microscopy using quantitative image analysis software.
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24 hours
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合作者和调查者
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
艰难梭菌感染的临床试验
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Deinove招聘中