Most cases of C. diff
infection occur in patients who are
taking antibiotics. Antibiotics can destroy a person's normal bacteria
found in the gut, allowing C. diff
bacteria to multiply and cause damage to the intestines.
‘A single fecal transplantation delivered by enema is no more effective than the existing standard of care for recurrent Clostridium difficile infection (RCDI), administration of oral vancomycin taper.’
Fecal transplant (FT), also known as a stool transplant, is the process of
transplanting fecal bacteria from a healthy individual into a recipient
with a disease presumed to be caused by the disruption of the microbiota
- natural bacteria - of the gut. The goal of FT is to restore the gut's
microbiota by introduction of healthy bacterial flora through a stool
infusion. Over the last few years, FT has become increasingly popular
for treating recurrent CDI.
Researchers at the University Health Network have found that when treating recurrent Clostridium difficile
infection (RCDI), a single fecal transplantation delivered by enema is
no more effective than the existing standard of care for RCDI,
administration of oral vancomycin taper. The findings were published
recently in the journal Clinical Infectious Diseases
Over the last decade, FT has re-emerged as a promising treatment for
RCDI with recent studies showing it to be highly effective. In an
effort to measure the true effectiveness of FT, the UHN team launched a
phase 2/3, single center, open-label trial, where study participants
experiencing an acute episode of RCDI were randomly assigned to receive
either 14 days of oral vancomycin therapy followed by a single FT of
fresh donor stool via enema, or a six week taper of oral vancomycin
After analyzing the results of the first 30 patients, the team
terminated the study since they found no significant difference between
the treatments. In fact, a futility analysis showed that should the
study have been completed, it is highly unlikely that FT would show
benefit over oral vancomycin taper. This is the first study of its kind
to compare FT to the current standard of care for RCDI.
"These findings are quite interesting and show that we have a lot to
learn as to how well fecal transplantation works compared to the
standard of care before it becomes a mainstream treatment," says Dr.
Susy Hota, Medical Director, Infection Prevention and Control Program,
University Health Network. "More research is needed into the many
factors that influence the effectiveness of FT, such as donor and
patient selection, FT manufacturing, how it is delivered to the patient,
the number of times FT needs to be given, and any other variables that
could improve outcomes."
Today's results, however, indicate that more research needs to be
done to determine whether this treatment is actually more effective
than the standard of care, and specifically, how to obtain the best
results from FT. The study also highlights that there is also much to
learn about the long-term implications of FT.
"In light of our results, I would caution a blanket approach of FT
to treat RCDI," says Dr. Hota. "The FT field is still evolving and,
given as yet undefined long-term effects of manipulating the gut's
microbiota, it should be approached with caution."
In an effort to provide more data about the long term health effects
of FT, Dr. Hota, co-lead Dr. Susan Poutanen and colleagues at UHN,
Sinai Health System and the University of Toronto founded the Microbiota
Therapeutics Outcomes Program (MTOP). A multi-disciplinary,
collaborative research program, the MTOP is conducting studies to
measure long term health outcomes from FT when it is used to treat C. diff
and several other health conditions.