The US Food and Drug Administration (FDA) has approved the first pill made from donated human feces, the agency announced Wednesday.
This is the second treatment derived from human feces ever approved. The first was an enema treatment, approved for use in December 2022, reported the live science.
Previously, these “faecal microbiota transplants” were considered experimental treatments and therefore difficult to access for patients.
The newly approved pill, called Vowstcontains live bacteria and is approved for use in people aged 18 years and older for preventive treatment of recurrent infections with the bacteria Clostridioides difficile.
A Clostridioides difficile it is often acquired in healthcare settings after patients have taken antibiotics for a different infection.
Antibiotics can upset the balance of bacteria that normally populate the gut, which gives the Clostridioides difficile the opportunity to proliferate. The rapidly replicating bacteria secrete toxins that can cause diarrhea, abdominal pain, fever and colitis (inflammation of the colon) and, in some cases, organ failure and death.
The infections by Clostridioides difficile are associated with about 15,000 to 30,000 deaths per year in the USaccording to the FDA.
The Centers for Disease Control and Prevention reported that people recovering from Clostridioides difficile may develop the infection again within two to eight weeks of recovery.
The risk of these recurring infections increases each time a person contracts Clostridioides difficilein part because the antibiotics used to treat them further disrupt the gut microbiome, the community of microorganisms in the lower digestive tract.
So-called faecal microbiota products, made from healthy human gut bacteria, offer a new way to preventClostridioides difficile recurring, essentially replenishing the gut microbiome.
And now, with Vowst’s approval, there is a version of the treatment that can be given orally, rather than the liquid treatment given into the patient’s rectum.
“The availability of a fecal microbiota product that can be taken orally is a significant step forward in treatment advancement and accessibility for individuals who have experienced this potentially fatal disease,” said Peter Marks, director of the Center for Evaluation and FDA Biological Research.
Vowst’s treatment regimen involves taking four capsules a day for three days in a row. Patients start taking the drug two to four days after finishing a course of antibiotics for the Clostridioides difficile.
The donated stool used to make the pills is carefully analyzed for detect transmissible pathogens before being used in manufacturing. But taking Vowst still carries some risk of exposure to pathogens as well as food allergens, the FDA warned.
In clinical trials, the most common side effects of Vowst were abdominal bloating, fatigue, constipation, chills and diarrhoea. They occurred more frequently in treated patients than in those receiving placebo.
In a comparison between about 90 people who received the pills and 90 who did not, people in the treated group had a 12.4% rate of infection recurrence in the eight weeks following recovery from a first flare-up, while the untreated group had a recurrence rate of 39.8%.
ZAP // 
