For the first time, the Food and Drug Administration (FDA) has approved a treatment made with donated human feces. the agency said (opens in new tab) Wednesday (November 30). The treatment called Rebyota includes intestines bacteria is obtained from the stool of healthy human donors and is approved for the prevention of a potentially life-threatening bacterial infection.
By administering the liquid treatment through a tube into a patient’s rectum, physicians can help restore balance to the patient’s gut microbiome, the community of microbes that live in the lower digestive tract.
Rebyota is approved for use in people aged 18 and over who have recently been treated for recurrent infections with the bacterium Clostridioides difficilecommonly called C. diff short. C. diff can quickly take over the gut when the normal microbiome is disrupted—for example, as a result of antibiotic use. People aged 65 and over, people with compromised immune systems, and people who have recently been in a hospital or nursing home are at the highest risk of infection. As C. diff When the bacteria multiply in the gut, they release toxins that cause diarrhea, abdominal pain, fever, and more inflammation of the large intestine (colitis). Sometimes the infections can lead to organ failure and even death, according to the FDA.
C. diff it is estimated to cause about half a million infections each year in the United States, and about 1 in 6 patients who develop the infection will get it again within two to eight weeks of recovery, according to the Centers for Disease Control and Prevention (opens in new tab).
Related: “Poop Pills” work just as well as traditional stool transplants
These recurring infections can be treated with antibiotics, but the drugs aren’t always effective against aggressive, antibiotic-resistant strains of C. diffand moreover, they can further disrupt the microbiome and sometimes make the infection worse The scientist (opens in new tab). To get to the root cause of the problem—the imbalanced gut microbiome—doctors are increasingly turning to so-called fecal microbiota transplants.
These transplants, previously considered an “investigative treatment” by the FDA, involve transferring screened donor stool into the patient’s intestines via a colonoscopy, enema, or pill. However, sourcing and screening the stool presents a challenge, meaning the grafts were not readily available everywhere and the lack of an FDA-approved product means the therapy is often not covered by insurance, The Scientist reported.
But now Rebyota is available as the first FDA-approved “fecal microbiota product.” In a late-stage clinical trial, single-dose treatment reduced the rate of C. diff Relapses by 29.4% in the eight weeks after antibiotic treatment compared to placebo Stat reported (opens in new tab). Taking into account two clinical trials of the treatment, the treatment success rate “was significantly higher in the Rebyota group (70.6%) than in the placebo group (57.5%),” the FDA noted.
“Today’s approval of Rebyota is a step forward in the care of patients with relapses C. difficile infection [CDI],” dr Peter Marks (opens in new tab), director of the FDA’s Center for Biological Agents Evaluation and Research, said in the agency’s statement. “As the first FDA-approved fecal microbiota product, today’s action represents an important milestone as it provides an additional approved option to prevent recurrent CDI.”
In clinical trials, the most common side effects of Rebyota were abdominal pain, diarrhea, gas, bloating, and nausea. And although donated feces are carefully screened for pathogens, the treatment carries some risk of transmitting infectious agents and may also contain food allergens, the FDA noted. “The potential of the product to produce side effects due to food allergens is unknown,” the agency’s statement said.