An experimental medical treatment where a patient is given a fecal transplant in order to reset their gut health has been found to have more risks than previously thought.
The United States Food and Drug Administration (FDA) has issued a warning about the procedure this week after two patients contracted serious drug-resistant infections following the procedure.
One patient ultimately succumbed to the infection.
Fecal transplants, or fecal microbiota transplantation (FMT), are being tested as a way to ‘reset’ the bacteria in a person's gut.
A patient has their gut microbe 'scrubbed’ clean with antibiotics then donated gut bacteria is inserted into the clean environment.
FMT proven to work despite risks
The transplant usually happens via an enema but is also being tested as an oral capsule. Severe imbalances in microbiome gut is linked to conditions such as irritable bowel syndrome, inflammatory bowel disease (IBD), and possibly, even, obesity. The most common use of FMT has been for Clostridium difficile, or C. diff. infection (CDI).
This excruciating infection can cause chronic diarrhea, as well as other issues. In small trials of FMT, the cure rate has been as high as 90%.
Patient dies after contracting superbug
In a recent investigational trial, two patients received transplants from the same donor.
Both contracted an invasive infection caused by multidrug-resistant Escherichia coli (E.coli). One patient died as a result of the infection.
The remaining fecal sample was tested and found to contain the same E. coli strain.
“FDA is informing members of the medical and scientific communities and other interested persons of the potential risk of transmission of [multidrug-resistant organisms] by FMT and the resultant serious adverse reactions that may occur,” the agency said in its safety brief.
FDA cracks down on trials
The FDA says the infection may have been prevented if better screening of donor samples was done.
Trials of FMT began in 2013. At that time, the FDA said they would take a light approach to regulation as long as doctors exhaustively wanted patients to be aware of the likely risks of the procedure.
However, thanks to these recent infection cases, the FDA says it will now demand that all donors be screened. The screening will be for risk factors that would indicate they are a superbug host, as well as have test samples for these kinds of bacteria.
Future patients involved in the trials will also need to be informed about these newly identified risks.
“Today’s safety communication underscores the importance of why new therapies are thoroughly studied to ensure the benefits of taking them outweigh the risks to patients, and we will continue to aggressively monitor clinical trials to ensure patients are protected when safety concerns arise,” Peter Marks, director of FDA’s Center for Biologics Evaluation and Research, said in an FDA statement.