0The U.S. Food and Drug Administration (FDA) has approved the first pill manufactured from donated human poop, the agency announced Wednesday (April 26). It’s the second human poop-derived treatment ever approved; the first was an enema-based treatment cleared for use in December 2022.
Previously, such “fecal microbiota transplants” were considered investigational treatments and were therefore harder for patients to access and often not covered by insurance.
Like the approved enema treatment, the newly approved pill, called Vowst, also contains live bacteria and has been approved for use in people ages 18 and older as a preventive treatment for recurrent infections with the bacterium Clostridioides difficile . Called C. diff for short, this infection is often acquired in health care settings after patients have taken antibiotics for a different infection.
Antibiotics can disrupt the balance of bacteria that normally populate the gut, and this gives C. diff the opportunity to proliferate. The rapidly replicating bacteria secrete toxins that can lead to diarrhea, abdominal pain, fever and colitis (inflammation of the colon) and, in some cases, organ failure and death. C. diff infections are associated with about 15,000 to 30,000 deaths a year in the U.S., according to the FDA.
Those who recover from C. diff have a roughly 1 in 6 chance of developing the infection again within two to eight weeks of recovery, according to the Centers for Disease Control and Prevention . The risk of these recurrent infections increases each time a person gets C. diff , in part because the antibiotics used to treat them further disrupt the gut microbiome, the community of microorganisms in the lower digestive tract.
Read more at: www.newbreak.com