Efficacy and Safety of Fecal Microbiota Transplantation for Severe Clostridium Difficile Associated Colitis
Status:
Terminated
Trial end date:
2016-01-01
Target enrollment:
Participant gender:
Summary
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.