Fecal microbiota

Fecal microbiota, given either as a rectal transplant or in an oral formulation of live spores, is an FDA-approved option to prevent the recurrence of Clostridioides difficile infection (CDI) in patients given an antibacterial treatment for recurrent CDI. Although the incidence of CDI has declined and the number of cases requiring hospitalization has been lower over the years, the recurrence of CDI still represents a challenge. Recurrent CDI has a high risk of mortality and a high failure rate.

The use of fecal microbiota transplantation is a treatment alternative for patients with recurrent CDI, also associated with lower costs and patient waiting times. For this type of therapy to be efficient, qualified donors must be selected. Human fecal matter is then tested for a panel of transmissible pathogens and processed with methods aimed at preserving bacterial viability. The purpose of fecal microbiota transplantation is to restore gut microbiota and replace microbes with healthy host microbiota.

REBYOTA, a live fecal microbiota suspension for rectal use, was approved by the FDA in November 2022. In April 2023, the agency also approved VOWST, a capsule formulation of live fecal microbiota spores for oral administration.