A new case study highlights the potential fecal transplant infection risks, indicating that there is a need for enhanced donor screening to avoid drug-resistant bacterium being spread through the process, which is used to treat recurrent C. difficile colitis.
In a report published this week in the New England Journal of Medicine, doctors at Massachusetts General Hospital indicate that two fecal matter transplant (FMT) recipients contracted a drug resistant E. coli bacteria from the same stool donor, ultimately resulting in the death of one of the patients.
Fecal transplants, which are also referred to as bacteriotherapy, involve the use of stool from a healthy donor that is transferred into the gastrointestinal tract of individuals suffering from recurrent C. diff, which can lead to Clostridium difficile-associated diarrhea (CDAD), with persistent diarrhea, watery stool, abdominal pain and fever.
According to the case report, two patients with C. diff diagnosis received investigational fecal transplants, and subsequently developed a bacterial infection known as extended-spectrum beta-lactamase (ESBL)-producing Escherichia coli, a drug-defeating enzyme strain of E. coli.
Researchers determined through genomic sequencing that both patients from the clinical trials received FMT’s from the same stool donor, which was contaminated with the drug resistant E.coli infection.
Fecal transplants are intended to introduce healthy fecal matter into the intestinal tract, as it is believed the good bacteria will replace or replenish the bad bacteria. Although largely an experimental treatment, it is thought to improve biological factors like food break down, hormones, and the immune response.
The procedures 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. Some studies have shown fecal transplant can cure 80 to 90% of Clostridium difficile infections, which are highly resistant to antibiotics.
Fecal transplants are done using a variety of methods, none of which have been specifically approved or regulated by the U.S. Food and Drug Administration (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.
The FDA issued fecal transplant guidance in 2013, indicating there were certain conditions where fecal transplants could be used to treat C. diff infections in patients who haven’t responded to standard therapies. However, each scenario called for a consent statement indicating the treatment was investigational, and included a warning of the potential serious risk of transmission of antibiotic resistant bacteria.
The agency has since introduced new protections for patients seeking fecal transplants. Those protections include donor screening with questions that address risk factors for colonization of drug resistant bacteria as well as drug resistant testing of stool.
Earlier this month the FDA scheduled a hearing for November 4 to get public input on the use of fecal microbiota for transplantation among patients who are not responsive to standard C. difficile treatments. 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.