The US FDA has granted approval for the first oral live microbiota product (spores, live-brpk) for the prevention of recurrent Clostridium difficile infections (rCDIs) in patients aged ≥18 years following antibiotic treatment. It will be marketed by the name of Vowst and contains live bacteria. It is not indicated for the treatment of recurrent CDIs.

Dose: 4 capsules once daily for 3 consecutive days; the spores then germinate and replicate in the gastrointestinal tract.

Adverse effects: Fatigue, abdominal bloating, diarrhea, constipation and chills

Warning and precautions

• There may be a risk of transmission of infectious pathogens since it is prepared from donated human fecal matter.
• It may contain food allergens.

The approval was based on the results of the ECOSPOR III and IV trials of patients with recurrent CDIs that compared it with placebo. In the ECOSPOR III trial published in the New England Journal of Medicine in January 2022, 88% of patients treated with the novel product had no recurrence of infection after 8 weeks of treatment compared to 60% among the placebo-recipients. In the ECOSPOR IV trial published this year in JAMA Network Open in February, the overall recurrent rate was 8.7% at week 8 and 13.7% at week 24.

Source

1. FDA News Release. Available at: https://www.fda.gov/news-events/press-announcements/fda-approves-first-orally-administered-fecal-microbiota-product-prevention-recurrence-clostridioides. April 26, 2024. Accessed on: April 26, 2024.