Pathogenic Mechanisms in C Diff Infection and Colitis

Clostridium Difficile Infection Clinical Trial

Official title:

Pathogenic Mechanisms in Clostridium Difficile Infection and Colitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01930032
• Other study ID #: 2013P000174
• Status: Completed
• Phase: N/A
• First received: August 20, 2013
• Last updated: March 6, 2017
• Start date: August 2013
• Est. completion date: January 2014

Study information

• Verified date: March 2017
• Source: Beth Israel Deaconess Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Clostridium Difficile Infection
• Colitis
• Communicable Diseases
• Infection

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Beth Israel Deaconess Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Binding of Toxin A (and B) to TLR9 on the human colorectal epithelial cell surface	As assessed by confocal fluorescence microscopy	24 hours
Secondary	effects of a TLR9 antagonist (ODN-TTAGGG) on toxin binding	The change of mean toxin fluorescence on colonocytes will be measured by confocal microscopy using quantitative image analysis software.	0 hours
Secondary	Binding of Toxin A (and B) to TLR9 on the human colorectal epithelial cell surface	as assessed by confocal fluorescence microscopy	0 hours
Secondary	Binding of Toxin A (and B) to TLR9 on the human colorectal epithelial cell surface	As assessed by confocal fluorescence microscopy	6 hours
Secondary	Effects of a TLR9 antagonist (ODN-TTAGGG) on toxin binding	The change of mean toxin fluorescence on colonocytes will be measured by confocal microscopy using quantitative image analysis software.	6 hours
Secondary	Effects of a TLR9 antagonist (ODN-TTAGGG) on toxin binding	The change of mean toxin fluorescence on colonocytes will be measured by confocal microscopy using quantitative image analysis software.	24 hours