Ignite Creation Date:
2025-12-24 @ 5:23 PM
Ignite Modification Date:
2026-01-01 @ 8:11 AM
Study NCT ID:
NCT01309750
Status:
TERMINATED
Last Update Posted:
2017-01-25
First Post:
2011-03-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Small Bowel Transit Time in Clostridium Difficile Colitis
Sponsor:
Corewell Health East
Organization:
Study Overview
Official Title:
Small Bowel Transit Time in Clostridium Difficile Colitis
Status:
TERMINATED
Status Verified Date:
2012-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
logistics
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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. 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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: