Gut microbiota turned FDA-approved pill!

The human gut microbiota continues to amaze with new discoveries of its impact on our health and disease. Now, the FDA has approved the first pill of the human gut microbiota to be used as a therapeutic… made from human feces!

Vowst (SER-109) is a cocktail of donors’ live bacteria now indicated for US adults to prevent recurrent Clostridioides difficile infection (CDI), which causes severe gastrointestinal consequences and may be life-threatening. The CDC estimates there were >200,000 CDI cases and >12,000 related deaths in the US in 2017. CDI is often acquired in healthcare settings after patients have taken antibiotics, which disrupt the composition of the gut microbiota and allow overgrowth of the C. difficile bacterium. Then, patients who recover from CDI are at increased risk of becoming infected again soon after.

Vowst is intended to replenish the gut with “healthy” bacteria, primarily from the Firmicute phylum. In the phase III ECOSPOR III trial, only 12% of patients in the Vowst group experienced CDI recurrence vs. 40% in the placebo arm after 8 weeks. No serious adverse events or deaths were deemed treatment-related.

Until now, efforts to change the gut microbiota to address health issues have mostly involved fecal transplants, which can be difficult to administer rectally and unpleasant for patients. We’re excited to see where this promising new oral and outpatient approach to health management goes next!

Written by Danyelle Liddle