New donor screening protocols for clinical trials involving fecal microbiota transplantation

Back in May, I wrote a blog post about fecal microbiota transplantation (FMT), or stool transplantation. FMT is considered standard-of-care therapy to treat recurrent Clostridium difficile (C. diff) infections. In this procedure, stool from a healthy donor is placed into the gut of a patient, usually via colonoscopy, to restore helpful bacteria that help protect against recurrent C. diff infection (rCDI). An important event occurred after my initial post. On June 13, 2019, the FDA issued a safety alert concerning the risk of transmission of multi-drug resistant organisms (MDRO) through FMT. MDROs are bacteria that are resistant to one or more antibiotics. Safety alert leaves many questions unanswered The safety alert was issued in response to the transmission of a specific MDRO from donor stool into two patients following FMT. Tragically, one of these individuals died. The FDA announcement provides very few details regarding these cases, and it does not provide information on the cause of this patient’s death. What is known is that these two patients were given FMT as part of a research protocol and not as part of clinical care to treat rCDI. As I mentioned in my previous post, FMT is supported by guidelines, but is still considered investigational and is not currently FDA-approved. FMT can be performed for clinical care to treat rCDI. But an FMT for any other indication can only be performed in the setting of a clinical trial. The FDA has not yet disclosed the indication o...
Source: Harvard Health Blog - Category: Consumer Health News Authors: Tags: Health Infectious diseases Safety Tests and procedures Source Type: blogs