- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01309750
Small Bowel Transit Time in Clostridium Difficile Colitis
January 23, 2017 updated by: William Beaumont Hospitals
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.
Study Overview
Status
Terminated
Conditions
Intervention / 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 Type
Observational
Enrollment (Actual)
1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Michigan
-
Royal Oak, Michigan, United States, 48073
- William Beaumont Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients with clostridium difficile colitis.
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Under age 18
- pregnant
- need for gastric motility medications
- need for anti-diarrheal medication
- need for surgery
- previous small bowel or gastric surgery
- inability to drink nuclear tracer without nasogastric tube in place
- hypotension requiring vasoactive agents
- APACHE II score greater than 30
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
C. diff
Patients with Clostridium difficile colitis admitted to the intensive care unit will be the study group.
|
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.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Marc B Grodsky, William Beaumont Hospitals
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2011
Primary Completion (Actual)
February 1, 2012
Study Completion (Actual)
February 1, 2012
Study Registration Dates
First Submitted
March 3, 2011
First Submitted That Met QC Criteria
March 3, 2011
First Posted (Estimate)
March 7, 2011
Study Record Updates
Last Update Posted (Estimate)
January 25, 2017
Last Update Submitted That Met QC Criteria
January 23, 2017
Last Verified
September 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2011-008
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Clostridium Difficile Colitis
-
Jewish General HospitalTerminatedFulminant Clostridium Difficile ColitisCanada
-
University of Wisconsin, MadisonAgency for Healthcare Research and Quality (AHRQ)Enrolling by invitationClostridium Difficile Infection | Clostridium Difficile | C Difficile ColitisUnited States
-
Genzyme, a Sanofi CompanyCompletedClostridium Difficile-Associated Diarrhea | Antibiotic-associated Diarrhea | Clostridium Enterocolitis | Clostridium Difficile Diarrhea | Antibiotic-associated ColitisUnited States, Canada, United Kingdom, Puerto Rico
-
Massachusetts General HospitalTerminatedClostridium Difficile ColitisUnited States
-
National Institute of Allergy and Infectious Diseases...Completed
-
Duke UniversityRecruitingClostridium Difficile ColitisUnited States
-
William Beaumont HospitalsBeaumont HospitalWithdrawnClostridium Difficile ColitisUnited States
-
Catholic University of the Sacred HeartCompletedClostridium Difficile | Pseudomembranous Colitis
-
University of VirginiaImperial College LondonRecruitingClostridium Difficile Infection | Clostridium Difficile Diarrhea | Clostridioides Difficile Infection | Clostridia Difficile ColitisUnited States
-
SanofiTerminatedClostridium Difficile Infection-associated Diarrhea and ColitisChina
Clinical Trials on Small Bowel Transit Study
-
Nantes University HospitalRecruiting
-
University Hospital FreiburgRecruitingGastroIntestinal BleedingGermany
-
Asian Institute of Gastroenterology, IndiaCompletedSmall Bowel Disease | Small Bowel Ulcers | Capsule Endoscopy | Small Bowel Tumor
-
The Cleveland ClinicMedtronicWithdrawn
-
Vanderbilt University Medical CenterActive, not recruitingObesity | Malnutrition | Weight Loss | Micronutrient DeficiencyUnited States
-
WellSpan HealthChristiana Care Health Services; University of California, IrvineCompletedSmall Bowel ObstructionUnited States
-
Odense University HospitalCompletedSimulation | Endoscopy | Education | Small Bowel Disease | Small Bowel Capsule EndoscopyDenmark
-
University of Southern CaliforniaCompletedObscure Gastrointestinal Bleeding (Occult or Overt)United States
-
Mayo ClinicMedtronic - MITGCompletedCrohn's DiseaseUnited States
-
Sykehuset i Vestfold HFOslo University Hospital; Helse Sor-Ost; University of Geneva, Switzerland; Car...RecruitingQuality of Life | Small Bowel Cancer | Lymph Node Metastases | Small Bowel Carcinoid Tumor | Tumor MetastasisNorway