Small Bowel Transit Time in Clostridium Difficile Colitis

This study has been terminated.
(logistics)
Sponsor:
Information provided by (Responsible Party):
Marc Grodsky, William Beaumont Hospitals
ClinicalTrials.gov Identifier:
NCT01309750
First received: March 3, 2011
Last updated: September 17, 2012
Last verified: September 2012
  Purpose

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.


Condition Intervention
Clostridium Difficile Colitis
Radiation: Small Bowel Transit Study

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Small Bowel Transit Time in Clostridium Difficile Colitis

Further study details as provided by William Beaumont Hospitals:

Enrollment: 1
Study Start Date: April 2011
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
C. diff
Patients with Clostridium difficile colitis admitted to the intensive care unit will be the study group.
Radiation: Small Bowel Transit Study
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with clostridium difficile colitis.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01309750

Locations
United States, Michigan
William Beaumont Hospital
Royal Oak, Michigan, United States, 48073
Sponsors and Collaborators
William Beaumont Hospitals
Investigators
Principal Investigator: Marc B Grodsky William Beaumont Hospitals
  More Information

No publications provided

Responsible Party: Marc Grodsky, Principal Investigator, William Beaumont Hospitals
ClinicalTrials.gov Identifier: NCT01309750     History of Changes
Other Study ID Numbers: 2011-008
Study First Received: March 3, 2011
Last Updated: September 17, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Colitis
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on October 02, 2014