The US Food and Drug Administration (FDA) has approved Vowst, the first stool pill for the prevention of recurrence of Clostridioides difficile infection (CDI) in people 18 years of age and older, which causes in USA between 15,000 and 30,000 deaths each year.
As explained by the FDA in a statement, Vowst’s dosing regimen is four capsules taken once a day, for three consecutive days. This pill contains live bacteria and is made from human fecal matter that has been donated by qualified individuals. Although donors and donated stool are tested for possible communicable pathogens, this pill may carry the risk of transmitting infections. It may also contain food allergens, and the FDA advises that its potential to cause adverse reactions due to food allergens is unknown.
“Today’s approval gives patients and healthcare providers a new way to help prevent recurrent C. difficile infection,” said Peter Marks, director of the FDA’s Center for Biologics Research and Evaluation. “The availability of an orally takeable fecal microbiota product is an important step forward in advancing patient care and accessibility for people who have experienced this potentially life-threatening disease.”
The human intestinal tract contains millions of microorganisms, often referred to as the “gut flora” or “gut microbiome.” Certain situations, such as taking antibiotics to treat an infection, can change the balance of microorganisms in the intestine, allowing the bacteria that causes it to multiply and release toxins that cause diarrhea, abdominal pain, and fever, and in some cases, organ failure and even death.
Other risk factors that may increase the risk of CDI include being older than 65 years, hospitalization, residence in a nursing home, a weakened immune system, and/or a prior history of CDI. After recovering from CDI, people can get the infection again, often multiple times, something known as recurrent CDI. The risk of additional recurrences increases with each infection, and treatment options for recurrent CDI have, until now, been limited. It is believed that the administration of fecal microbiota facilitates the restoration of the intestinal flora to prevent new episodes.
