Pathogenic Mechanisms in C Diff Infection and Colitis
Pathogenic Mechanisms in Clostridium Difficile Infection and Colitis
1 other identifier
observational
24
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Aug 2013
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2013
CompletedFirst Submitted
Initial submission to the registry
August 20, 2013
CompletedFirst Posted
Study publicly available on registry
August 28, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2014
CompletedMarch 8, 2017
March 1, 2017
5 months
August 20, 2013
March 6, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Binding of Toxin A (and B) to TLR9 on the human colorectal epithelial cell surface
As assessed by confocal fluorescence microscopy
24 hours
Secondary Outcomes (5)
effects of a TLR9 antagonist (ODN-TTAGGG) on toxin binding
0 hours
Binding of Toxin A (and B) to TLR9 on the human colorectal epithelial cell surface
0 hours
Binding of Toxin A (and B) to TLR9 on the human colorectal epithelial cell surface
6 hours
Effects of a TLR9 antagonist (ODN-TTAGGG) on toxin binding
6 hours
Effects of a TLR9 antagonist (ODN-TTAGGG) on toxin binding
24 hours
Study Arms (1)
All subjects
Eligibility Criteria
Subjects will be selected from patients undergoing a routine screening colonoscopy at Beth Israel Deaconess Medical Center
You may qualify if:
- Age greater than 18 yrs and less than 75 years
- Undergoing a clinically indicated colonoscopy
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
Biospecimen
Colonic biopsy samples
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Medicine
Study Record Dates
First Submitted
August 20, 2013
First Posted
August 28, 2013
Study Start
August 1, 2013
Primary Completion
January 1, 2014
Study Completion
January 1, 2014
Last Updated
March 8, 2017
Record last verified: 2017-03