Efficacy and Safety of Fecal Microbiota Transplantation for Severe Clostridium Difficile Associated Colitis
Clostridium difficile has become one of the leading causes of hospital acquired infections, and is associated with increased mortality. Patients with C. difficile associated disease (CDAD) possess deficiencies in 'normal' fecal microbial composition, most likely as a result of earlier antibiotic usage. The current standard of care treatment for severe C. difficile, which consists of antibiotics, does not restore the microbiota. Restoration of the normal colonic microbiota by fecal microbiota transplantation (FMT) may enable reversion colonic microbial population to a more 'normal'state and lead to cure.
A few patients develop severe CDAD which may be complicated by adynamic ileus, or toxic megacolon. The management in this context is based on limited data, and for some the only available option is sub-total colectomy.
Although FMT is by no means a new therapeutic modality, there is limited information on its use for the treatment of acute CDAD, including severe CDAD. Because of the high morbidity and mortality associated with treatment of patients with severe CDAD, and because the evidence supporting the current recommendations is weak and based upon the demonstration that FMT is an effective strategy to re-establish a balanced intestinal microbiota with resultant cure of recurrent CDAD, we propose to study the efficacy and safety of FMT for severe CDAD.
Patients with severe CDAD can be divided into two operational groups; those that have diarrhea and those that suffer from adynamic ileus. We propose to apply FMT through colonoscopy for all patients because current data suggest that the overall success rate of FMT for recurrent CDAD with lower gastrointestinal tract FMT was higher than FMT through the upper gastrointestinal tract. In addition, for patients with adynamic ileus and toxic megacolon (i.e., the population with the highest CDAD-associated morbidity and mortality), intra-colonic FMT administration is the preferred alternative.
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Efficacy and Safety of Fecal Microbiota Transplantation for Severe Clostridium Difficile Associated Colitis|
- Resolution of severe CDAD [ Time Frame: 2 weeks ]decrease of diarrhea, time to decrease in elevated white blood cell count
- Recurrence of CDAD [ Time Frame: 2 weeks ]relapse
- all cause mortality [ Time Frame: 30 days ]
- Need for colectomy [ Time Frame: 30 days ]
- Morbidity [ Time Frame: 1 weeks ]immediate colonoscopy-related complications, secondary infection
|Study Start Date:||November 2013|
|Estimated Study Completion Date:||December 2017|
|Estimated Primary Completion Date:||December 2017 (Final data collection date for primary outcome measure)|
Experimental: fecal microbiota transplant
fecal microbiota transplantation
|Drug: fecal microbiota transplantation|
Show Detailed Description
Please refer to this study by its ClinicalTrials.gov identifier: NCT01959048
|Hadassah Medical Center||Recruiting|
|Jerusalem, Israel, 91120|
|Contact: Jacob Strahilevitz, MD 972-2-6776543 email@example.com|
|Principal Investigator: Jacob Strahilevitz, MD|
|Principal Investigator:||Jacob Strahilevitz, MD||Hadassah Medical Organization|