Fecal Transplant in a Pill

In April, the U.S. Food and Drug Administration (FDA) approved Vowst, the first oral fecal-transplant pill. Loaded with live fecal microbiota, the medication is designed to prevent recurrence of Clostridioides difficile infection (CDI) after antibacterial treatment.

CDI is among the most common life-threatening bacterial infections: In 2019, the Centers for Disease Control and Prevention labeled it an urgent threat. Some 223,000 cases of CDI are reported annually in the United States, and it’s associated with as many as 12,800 deaths each year.

1. diff can be killed off with antibiotics, but the drugs also destroy beneficial gut bacteria, leaving sufferers more susceptible to future infections.

A fecal microbiota transplant (FMT) of healthy donor stools was originally administered via colonoscopy; the good bacteria then fought off the bad and rebuilt the microbiome in the process. In 2022, the FDA approved Rebyota, an FMT pharmaceutical that is injected into the rectum; the drug is designed to prevent recurrence of C. diff infection, according to the manufacturer.

Stool used in Vowst is tested for a variety of transmissible pathogens, but the FDA warns that it “may carry a risk of trans­mitting infectious agents . . . [and] food allergens.”