FDA To Hold Public Hearing On Safety, Effectiveness Of Fecal Transplants
The safety and risks with fecal matter transplants will be the topic of a public hearing hosted by federal regulators next month, which will examine the current policies and procedures surrounding use of fecal transplants to treat patients with Clostridium difficile (C. difficile) infections.
According to a federal register notice, the U.S. Food and Drug Administration (FDA) has scheduled a hearing for November 4, to obtain public information surrounding the use of fecal microbiota for transplantation (FMT) among patients who are not responsive to standard C. difficile treatments
C. diff infections can lead to Clostridium difficile-associated diarrhea (CDAD), causing persistent diarrhea, watery stool, abdominal pain and fever. It can eventually lead to more severe intestinal problems if not treated in a timely manner.
The infection is sometimes treated by using fecal transplants to replace or replenish good bacteria in the intestinal tract. It’s a largely experimental treatment, but has been found to improve biological factors like food break down, hormones, and the immune response.
Some studies suggest fecal transplant can cure 80% to 90% of C. difficile infections, which are highly resistant to antibiotics. Yet, it is unclear exactly how fecal transplants work to improve health conditions.
Fecal transplants are done using a variety of methods, none of which have been specifically approved or regulated by the FDA. Methods include swallowing pills of stool, freeze dried pieces, and hand mixed fresh stool. Each can be delivered using enemas, colonoscopies, swallowed, or with tubes threaded through the nose to the stomach.
Although unproven, fecal transplants are believed to have higher success rates because they do not disrupt protective bacteria in the gastrointestinal systems like antibiotics, thus allowing for a more effective defense treatment against the infection.
The hearing will review scientific data and other information to consider the most effective ways to continue developing FMT treatment to treat C. difficile infections.
The hearing announcement comes just months after one individual died and another became seriously ill due to the fecal transplant being tainted with antibiotic resistant bacteria.
The FDA issued a warning about fecal transplants in June 2019, indicating that two patients were not properly tested for extended-spectrum beta-lactamase (ESBL)-producing e. coli bacteria, which could result in life threatening infections.
The hearing is part of a new initiative by the FDA to implement new protections for patients seeking fecal transplants that include donor screening with questions that address risk factors for colonization of drug resistant bacteria as well as drug resistant testing of stool.