Clinical concerns and the increasing number of FMT proce-
dures performed by U.S. physicians recently led the U.S. Food
and Drug Administration (FDA) to release new guidelines that
define FMT as a biologic therapy that requires physicians to
obtain an investigational new drug (IND) application [37]. Shortly
after this guideline was a released, however, the FDA announced a
decision to exercise enforcement discretion in order to allow
physicians to perform FMT in patients with RCDI not responsive
to standard therapy. The urgency for further research into the
short- and long-term effects of FMT is highlighted by the fact that
the public awareness of FMT as a treatment option for RCDI has
increased to a degree where do-it-yourself protocols have become
available over the Internet and the procedure is being performed
without medical surveillance.