April 27, 2023 – People with the painful and often recurring form of the bacterial infection known as C. diff can now take a helpful treatment called fecal transplant therapy by simply swallowing a pill.
The FDA approved the treatment, called Vowst, this week. Previously, fecal transplants used only a more invasive method that transferred donor stools using a colonoscope, which is the instrument used during a colonoscopy.
Infection with the bacteria C. difficile (CDI) typically occurs in health care settings and is often related to an imbalance in the intestines after a person takes antibiotics. Symptoms include diarrhea, belly pain, and fever, but serious infections can lead to organ failure and death.
“The administration of fecal microbiota is thought to facilitate restoration of the gut flora to prevent further episodes of CDI,” the FDA explained in its approval announcement.
As many as 1 in 4 people who get the infection will have a recurrence, and each time the infection recurs, the chance of another episode increases. The FDA says between 15,000 and 30,000 people die annually due to C. difficile infection.
In a study of 182 people, 12% of those who took Vowst had a recurrence during an 8-week period, compared to 40% of people who were given a placebo pill, the FDA reported.
Each capsule of Vowst contains live bacteria, which is taken from human fecal matter from screened donors. The Vowst dosing plan is four capsules taken orally once a day, for 3 days in a row.
The company that makes Vowst, Seres Therapeutics, said it expects the product to be available in June.
“Recurrent C. difficile infection significantly impacts patients’ quality of life, both physically and emotionally, leaving many living in tremendous fear of future recurrences,” Christian John Lillis, executive director at the Peggy Lillis Foundation for C. diff Education and Advocacy, said in a statement. “Patients have been waiting for new treatment options that address a key concern: prevention of an additional CDI recurrence.”