What is a Fecal Transplant? FDA Issues Warning After Patient Dies From 'Invasive' Post-transplant Infection

The U.S. Federal Drug Administration (FDA) issued a warning about fecal transplants on Thursday after two patients developed "invasive" infections after going through the procedure. One of the patients died.

The donor stool used to treat both patients contained a dangerous drug-resistant bacteria: a fearsome type of E. coli bacteria that is resistant to numerous antibiotics, including penicillin.

Medical professionals did not test the sample for this kind of bacteria before it was used in the procedure.

Both patients had weakened immune systems, according to the FDA.

During a fecal transplant, medical staff give fecal matter containing beneficial bacteria from a healthy donor to a patient.

The procedure is called "fecal microbial transplantation," for short, as the Johns Hopkins Medicine website notes. It is also known as fecal bacteriotherapy.

Doctors should first screen a donor sample for infectious diseases. The FDA warning issued Thursday advises medical professionals test for multi-drug resistant organisms in all donor samples.

After screening, the healthy stool is typically mixed with a saltwater solution and applied to the colon during a colonoscopy, Johns Hopkins Medicine states. In some cases, a nasoduodenal tube, which is placed through the nose into the small bowel, is used instead.

Fecal Transplant, Death
File photo: A woman's legs and feet are pictured as she sits on a toilet. Getty

Such procedures may be used to treat recurrent cases of C. difficile colitis, the hospital website explains. This occurs when an infection with a bacteria called C. difficile leads to inflammation of the lining of the colon. C.diff infections usually take place in patients who have taken antibiotics, according to the CDC.

Healthy guts are full of bacteria, much of which is safe or even beneficial. But antibiotics can kill off the good bacteria along with the bad. When this happens, C.diff may start to "take over" and damage the lining of the colon, as the Johns Hopkins website explains.

Transplanting healthy fecal matter can help restore balance to the bacteria in the digestive tract, when further antibiotic treatments have failed.

Some studies have shown fecal transplants to be effective in up to 90 percent of C.diff patients. But the treatment is not without its drawbacks. It is not always effective, and may lead to complications.

A 2018 review of fecal transplants for immunocompromised patients with C.diff infections found some serious adverse events including death and treatment-related infection. The study was published in The Canadian Journal of Gastroenterology and Hepatology.

The authors noted these results showed were similar to those you would expect among fecal transplant patients with properly functioning immune systems.