How Is a Fecal Transplant Done? Here’s Why the FDA is Now Warning Patients About Them
Fecal transplants could cure people who suffer from C. diff. But they aren’t properly regulated yet.
“Poop transplants,” or what doctors refer to as fecal microbiota transplants (FMT), have been used in recent years as an experimental cure for Clostridium difficile, sometimes referred to as C. diff or C. difficile, which affects nearly half a million Americans each year.
C. diff is a type of bacteria that can produce toxins that attack the lining of your intestines and cause everything from diarrhea to an inflamed colon, which can be life-threatening.
“It’s only been a couple of years, [and] the FDA hasn’t technically approved this, but it [works] at a very high success rate,” Rabia De Latour, MD, gastroenterologist and assistant professor of medicine at NYU Langone Health tells Health. They’re currently done one of two ways. The first way entails inserting a tube through the anus or through the nose that connects to the colon where the donor stool is released. The second—and more experimental way—involves ingesting capsules or getting enimas containing donor stool. The overall goal of the transplant is to restore a healthy balance of gut bacteria to the recipient, which C. diff takes away from them. Donor stool can restore this balance.
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Fecal transplant donors
There are two ways patients can access fecal transplant donations. Dr. De Latour tells Health that four different pharmaceutical companies currently sell donated stool and donors get as little as $40 for their contribution. Daniel Freedberg, MD, a gastroenterologist at Columbia University Irving Medical Center notes that if a patient doesn’t want to buy donated stool from a pharmaceutical company, they can receive donated stool from a friend or family member.
Mayo Clinic notes that the stool of all FMT donors, whether a person donates to a pharmaceutical company or directly to a friend, should be screened for viruses, infectious bacteria, and parasites before their stool is donated and that FMT procedures have a success rate greater than 90%.
Fecal transplant patients
According to the American Gastroenterological Association (AGA), FMT candidates must have suffered from three different C. diff infections that resisted antibiotic treatment to be eligible for the procedure. FMT procedures are considered “successful” if the patient doesn’t have a C. diff relapse for 8 weeks after the procedure. And some patients may require more than one transplant if they have “stubborn” C. diff.
This seemingly simple fix can be costly too. Because FMTs aren’t FDA-approved, insurance companies don’t cover the procedure, and therefore patients must pay out-of-pocket upwards of $1,500 for one treatment. That might be a lot to pay especially considering there’s not enough safety regulation of the procedure.
Dr. De Latour says that, even though FMTs could be extremely beneficial for patients who suffer from recurring C. diff, which can be fatal, the treatments won’t be of use to people from all economic backgrounds until FMTs are covered by insurers and safely regulated.
Are fecal transplants safe?
Last week, the FDA issued a warning after the first-ever fecal transplant related death. In this statement, they explained that a harmful drug-resistant organism was transmitted to the colons of two recipients of donor stool. Specifically, the patients were infected with a bacterium called Escherichia coli, or E. coli, which caused an infection that proved fatal for one of the affected patients. E. coli can cause bloody diarrhea, vomiting, and abdominal cramps. Though the FDA’s warning didn’t call for FMT procedures to be halted in the US, the administration advises physicians to warn FMT patients about the possibility of infection caused by a drug-resistant organism.
“Because of these serious adverse reactions, FDA has determined that certain donor screening and stool testing protections are needed for any investigational use of FMT,” the statement says. The statement explains that testing procedures that are stricter than the existing ones need to be put in place.
Dr. Freedberg notes that doctors don’t yet know whether or not the deceased patient had opted to buy donated stool from a pharmaceutical company that sells it or if the FMT they received involved stool donated from a family member. But the FDA’s warning will make gastroenterologists nervous about receiving stool donations and screening them in-house. He believes doctors might now be more likely to encourage patients to buy donated stool from a pharmaceutical company since doctors won’t be as liable if that stool makes a patient ill. “I and other gastroenterologists are going to be scared to do it the old way,” he says.