Clostridium Difficile InfectionNCT01930032
Pathogenic Mechanisms in C Diff Infection and Colitis
An observational study of Clostridium Difficile Infection, run by Beth Israel Deaconess Medical Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Clostridium Difficile Infection
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2013to Jan 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects will be selected from patients undergoing a routine screening colonoscopy at Beth Israel Deaconess Medical Center
Who may be able to join
- Age greater than 18 yrs and less than 75 years
- Undergoing a clinically indicated colonoscopy
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
About this study
Official title: 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).
- 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.
Read the detailed 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.
- Conditions
- Clostridium Difficile Infection
- Keywords
- Clostridium difficile infection
- Medical subject headings
- Clostridium Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| All subjects | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Binding of Toxin A (and B) to TLR9 on the human colorectal epithelial cell surface
As assessed by confocal fluorescence microscopy
Measured: 24 hours
Secondary outcomes (5)
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.
Measured: 0 hours
Binding of Toxin A (and B) to TLR9 on the human colorectal epithelial cell surface
as assessed by confocal fluorescence microscopy
Measured: 0 hours
Binding of Toxin A (and B) to TLR9 on the human colorectal epithelial cell surface
As assessed by confocal fluorescence microscopy
Measured: 6 hours
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.
Measured: 6 hours
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.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2013 (estimated)
- Study startAug 2013
- Primary completionJan 2014
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clostridium Difficile InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ciaran Kelly, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01930032
- Sponsor's protocol ID
- 2013P000174
- Status last verified
- Mar 2017
- First submitted
- 20 Aug 2013
- Last updated
- 8 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pathogenic Mechanisms in Clostridium Difficile Infection and Colitis
- ClinicalTrials.gov ID
- NCT01930032
- Acronym / sponsor ID
- 2013P000174
- Conditions
- Clostridium Difficile Infection
- Keywords
- Clostridium difficile infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 28 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
- 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.
Detailed 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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All subjects | – | – |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects will be selected from patients undergoing a routine screening colonoscopy at Beth Israel Deaconess Medical Center
Key inclusion criteria (2 listed)
- Age greater than 18 yrs and less than 75 years
- Undergoing a clinically indicated colonoscopy
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
5 secondary outcomes
effects of a TLR9 antagonist (ODN-TTAGGG) on toxin binding
Time frame: 0 hours
Binding of Toxin A (and B) to TLR9 on the human colorectal epithelial cell surface
Time frame: 0 hours
Binding of Toxin A (and B) to TLR9 on the human colorectal epithelial cell surface
Time frame: 6 hours
Effects of a TLR9 antagonist (ODN-TTAGGG) on toxin binding
Time frame: 6 hours
Effects of a TLR9 antagonist (ODN-TTAGGG) on toxin binding
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Clostridium Difficile Infection, run by Beth Israel Deaconess Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Binding of Toxin A (and B) to TLR9 on the human colorectal epithelial cell surface (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2017.