Because investigational FMT is classified as an investigational drug by the FDA, no claims can be made about the procedure’s safety. However, analyses of patient outcomes following investigational FMT suggest that its potential therapeutic benefit outweighs the safety risks for most patients with recurrent C. difficile infections.
Moving forward, more randomized controlled trials and longer periods of patient follow-up are needed to improve our current understanding of the safety risks associated with investigational FMT. Rigorous donor screening is crucial to minimize the risk of transmitting pathogens as well as microbiome-mediated health conditions through donor stool.
You can find more information in our white paper titled "Current Evidence on the Safety of Fecal Microbiota Transplantation (FMT) for C. difficile infection." We have also compiled a list of publications on the safety of investigational FMT below.