Clostridium Difficile ColitisNCT01309750
Small Bowel Transit Time in Clostridium Difficile Colitis
An observational study of Clostridium Difficile Colitis, run by Corewell Health East at 1 site in United States.
Trial summary
Clostridium difficile is a bacteria that can infect the colon and cause severe diarrhea in patients after recent antibiotic use. The current standard of care treatment for severe C. diff. consists of oral vancomycin and/or intravenous metronidazole. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Clostridium Difficile Colitis
- What is being tested?
- Small Bowel Transit Study
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2011to Feb 2012
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with clostridium difficile colitis.
Who may be able to join
- ICU patient
- positive c. diff PCR or visualization of pseudomembranes on colonoscopy
- able to give consent or have representative to give consent
- ability to drink contrast or have a previously placed nasogastric tube
- approval from the intensivist on duty/ICU Attending physician
Who cannot join
- Under age 18
- pregnant
- need for gastric motility medications
- need for anti-diarrheal medication
- need for surgery
- previous small bowel or gastric surgery
Show all 9Show fewer
- inability to drink nuclear tracer without nasogastric tube in place
- hypotension requiring vasoactive agents
- APACHE II score greater than 30
Trial locations and contacts
1 site in 1 country.
United States1 site
William Beaumont Hospital
Royal Oak, Michigan, 48073
About this study
Clostridium difficile is a bacteria that can infect the colon and cause severe diarrhea in patients after recent antibiotic use. The current standard of care treatment for severe C. diff. consists of oral vancomycin and/or intravenous metronidazole. When treatment is unsuccessful, it can lead to need for removal of the entire colon or even death. In fact, mortality rates in the literature range from 11-37% for C. diff. The most commonly quoted mortality rate is 14% for severe infection. It is believed that the failure of treatment may stem from an adynamic ileus (paralysis of the small bowel). This ileus may prevent the oral vancomycin from reaching the colon and therefore it does not treat the problem. Vancomycin functions by direct contact with the colon. It is presumed that this paralysis of the small intestine is present but has never been proven. The objective of the study is to prove that there is an adynamic ileus present in c. diff colitis and therefore lead to investigations into improved treatment.
Read the detailed description
Patients in the intensive care unit are eligible to participate in the study A pregnancy test will be checked if applicable. Patients that are enrolled and consented in the study will be given 300ml of water containing 5 millicurie (mCi) of technetium-99m (Tc-99m) diethylenetriamine pentaacetate (DTPA). This nuclear tracer/water mix will either be drank orally or placed down a nasogastric tube to begin the study. The patient will have to have nothing else to eat or drink for the duration of the study. The patients will have a nuclear scan performed at 2, 4, and 6 hours after ingestion of the nuclear tracer. The images at 2 and 6 hours will be taken in the nuclear medicine department while the 4 hour image will be taken in the ICU. The 2 and 6 hour studies must be conducted in the nuclear medicine department to allow for special equipment to be used. This equipment is necessary to allow for computer calculation to be made. The 4 hour scan is to check for progress of the tracer and does not require calculations/measurements. Therefore, a mobile scanner can be utilized. The image will be taken for 60 seconds. The images obtained will then be interpreted by the nuclear medicine department to determine the transit time of the tracer from the stomach to the terminal ileum and cecum. The data obtained from the subjects will be compare to previously obtained data for normal subjects. A normal study has been defined as 40% of the tracer reaching the terminal ileum by 6 hours. Any time longer than 6 hours is deemed an abnormal study with delayed small bowel transit time.
- Conditions
- Clostridium Difficile Colitis
- Being tested
- Small Bowel Transit Study
- Medical subject headings
- Enterocolitis, Pseudomembranous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Small Bowel Transit StudyRadiation
Patients that are enrolled and consented in the study will be given 300ml of water containing 5 millicurie (mCi) of technetium-99m (Tc-99m) diethylenetriamine pentaacetate (DTPA). This nuclear tracer/water mix will either be drank orally or placed down a nasogastric tube to begin the study. The patient will have to have nothing else to eat or drink for the duration of the study. The patients will have a nuclear scan performed at 2, 4, and 6 hours after ingestion of the nuclear tracer.
| Study group | Role | What they receive |
|---|---|---|
| C. diff | Patients with Clostridium difficile colitis admitted to the intensive care unit will be the study group. Receives: Radiation: Small Bowel Transit Study |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2011 (estimated)
- Study startApr 2011
- Primary completionFeb 2012
- Study completionFeb 2012
Why it stopped: logistics
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clostridium Difficile ColitisStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corewell Health East
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marc B Grodsky, Principal investigator, Corewell Health East
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01309750
- Sponsor's protocol ID
- 2011-008
- Status last verified
- Sep 2012
- First submitted
- 3 Mar 2011
- Last updated
- 25 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Small Bowel Transit Time in Clostridium Difficile Colitis
- ClinicalTrials.gov ID
- NCT01309750
- Acronym / sponsor ID
- 2011-008
- Conditions
- Clostridium Difficile Colitis
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: logistics
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Corewell Health EastUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 7 Mar 2011 (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.
Clostridium difficile is a bacteria that can infect the colon and cause severe diarrhea in patients after recent antibiotic use. The current standard of care treatment for severe C. diff. consists of oral vancomycin and/or intravenous metronidazole. When treatment is unsuccessful, it can lead to need for removal of the entire colon or even death. In fact, mortality rates in the literature range from 11-37% for C. diff. The most commonly quoted mortality rate is 14% for severe infection. It is believed that the failure of treatment may stem from an adynamic ileus (paralysis of the small bowel). This ileus may prevent the oral vancomycin from reaching the colon and therefore it does not treat the problem. Vancomycin functions by direct contact with the colon. It is presumed that this paralysis of the small intestine is present but has never been proven. The objective of the study is to prove that there is an adynamic ileus present in c. diff colitis and therefore lead to investigations into improved treatment.
Detailed description
Patients in the intensive care unit are eligible to participate in the study A pregnancy test will be checked if applicable. Patients that are enrolled and consented in the study will be given 300ml of water containing 5 millicurie (mCi) of technetium-99m (Tc-99m) diethylenetriamine pentaacetate (DTPA). This nuclear tracer/water mix will either be drank orally or placed down a nasogastric tube to begin the study. The patient will have to have nothing else to eat or drink for the duration of the study. The patients will have a nuclear scan performed at 2, 4, and 6 hours after ingestion of the nuclear tracer. The images at 2 and 6 hours will be taken in the nuclear medicine department while the 4 hour image will be taken in the ICU. The 2 and 6 hour studies must be conducted in the nuclear medicine department to allow for special equipment to be used. This equipment is necessary to allow for computer calculation to be made. The 4 hour scan is to check for progress of the tracer and does not require calculations/measurements. Therefore, a mobile scanner can be utilized. The image will be taken for 60 seconds. The images obtained will then be interpreted by the nuclear medicine department to determine the transit time of the tracer from the stomach to the terminal ileum and cecum. The data obtained from the subjects will be compare to previously obtained data for normal subjects. A normal study has been defined as 40% of the tracer reaching the terminal ileum by 6 hours. Any time longer than 6 hours is deemed an abnormal study with delayed small bowel transit time.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| C. diff | – | Radiation: Small Bowel Transit StudyPatients with Clostridium difficile colitis admitted to the intensive care unit will be the study group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with clostridium difficile colitis.
Key inclusion criteria (5 listed)
- ICU patient
- positive c. diff PCR or visualization of pseudomembranes on colonoscopy
- able to give consent or have representative to give consent
- ability to drink contrast or have a previously placed nasogastric tube
- approval from the intensivist on duty/ICU Attending physician
Key exclusion criteria (9 listed)
- Under age 18
- pregnant
- need for gastric motility medications
- need for anti-diarrheal medication
- need for surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Small Bowel Transit StudyPatients that are enrolled and consented in the study will be given 300ml of water containing 5 millicurie (mCi) of technetium-99m (Tc-99m) diethylenetriamine pentaacetate (DTPA). This nuclear tracer/water mix will either be drank orally or placed down a nasogastric tube to begin the study. The patient will have to have nothing else to eat or drink for the duration of the study. The patients will have a nuclear scan performed at 2, 4, and 6 hours after ingestion of the nuclear tracer. | Radiation | C. diff |
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early (reason given: logistics). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 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.
Marc B Grodsky principal investigator
Corewell Health East
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 Colitis, run by Corewell Health East 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 5 inclusion and 9 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: stopped early, as of the sponsor's last update on 25 Jan 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 was stopped early (reason given: logistics). Results are not available in the source record.
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.
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 25 Jan 2017.