FMT
represents the first entry in an emerging new class of drugs:
microbiota
therapeutics. As a complex drug, FMT is appropriately
regulated
by the FDA Office of Vaccines, Blood, and Biologics in the
United
States. Unlike probiotics, which are scientifically defined
as
live microorganisms that benefit human health, microbiota
therapeutics
explicitly target disease. FMT relies on established
microbial
communities designed by nature over millions of years
and
tested for decades in individual donors, establishing a very high
bar for researchers who wish to develop new therapeutics with
synthetic
microbial communities grown in bioreactors. However,
cultivated
synthetic communities may also theoretically lower the
potential
FMT-associated infectious risk, improve manufacturing
efficiency,
and have greater potential for intellectual property that
is
ultimately critical for successful commercialization.