Small Bowel Transit Time in Clostridium Difficile Colitis

NCT01309750 | Terminated DMC

• 1 other identifier: 2011-008
• Study Type: observational
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Clostridium Difficile Colitis

Study Arms (1)

C. diff

Patients with Clostridium difficile colitis admitted to the intensive care unit will be the study group.

Radiation: Small Bowel Transit Study

Interventions

Small Bowel Transit Study RADIATION

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.

C. diff

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with clostridium difficile colitis.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Corewell Health East: lead

Study Sites (1)

William Beaumont Hospital

Royal Oak, Michigan, 48073, United States

Location

MeSH Terms

Conditions

Enterocolitis, Pseudomembranous

Condition Hierarchy (Ancestors)

Clostridium Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Enterocolitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Marc B Grodsky

  Corewell Health East

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2011
• First Posted: March 7, 2011
• Study Start: April 1, 2011
• Primary Completion: February 1, 2012
• Study Completion: February 1, 2012
• Last Updated: January 25, 2017

Record last verified: 2012-09

Locations

US (1)