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Completed

NCT Number: NCT01930032

Pathogenic Mechanisms in C Diff 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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

Primary outcomes

  1. Binding of Toxin A (and B) to TLR9 on the human colorectal epithelial cell surface

    Time frame: 24 hours

    As assessed by confocal fluorescence microscopy

Secondary outcomes

  1. effects of a TLR9 antagonist (ODN-TTAGGG) on toxin binding

    Time frame: 0 hours

    The change of mean toxin fluorescence on colonocytes will be measured by confocal microscopy using quantitative image analysis software.

  2. Binding of Toxin A (and B) to TLR9 on the human colorectal epithelial cell surface

    Time frame: 0 hours

    as assessed by confocal fluorescence microscopy

  3. Binding of Toxin A (and B) to TLR9 on the human colorectal epithelial cell surface

    Time frame: 6 hours

    As assessed by confocal fluorescence microscopy

  4. Effects of a TLR9 antagonist (ODN-TTAGGG) on toxin binding

    Time frame: 6 hours

    The change of mean toxin fluorescence on colonocytes will be measured by confocal microscopy using quantitative image analysis software.

  5. Effects of a TLR9 antagonist (ODN-TTAGGG) on toxin binding

    Time frame: 24 hours

    The change of mean toxin fluorescence on colonocytes will be measured by confocal microscopy using quantitative image analysis software.

Sponsors and collaborators

Lead sponsor

Beth Israel Deaconess Medical Center

Other

Registry information

Official study title

Pathogenic Mechanisms in Clostridium Difficile Infection and Colitis

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Aug 28, 2013
Registry last updated
Mar 8, 2017

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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