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# FDA Approves Oral Fecal Microbiota Capsules
- URL: https://www.fdaweb.com/fda-approves-oral-fecal-microbiota-capsules/
- Published: 2023-04-27T12:00:00.000Z
- Updated: 2026-09-14T18:28:12.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5154315

FDA has approved a Seres Therapeutics BLA for Vowst (fecal microbiota spores, live-brpk), formerly called SER-109, an orally administered microbiota-based product to prevent recurrence of *C. difficile* Infection (CDI) in adults following antibacterial treatment for recurrent CDI (rCDI). The product is not indicated for treating CDI, according to the company.

“The availability of a fecal microbiota product that can be taken orally is a significant step forward in advancing patient care and accessibility for individuals who have experienced this disease that can be potentially life-threatening,” CBER director **Peter Marks** is quoted in a [release](https://www.fda.gov/news-events/press-announcements/fda-approves-first-orally-administered-fecal-microbiota-product-prevention-recurrence-clostridioides?ref=fdaweb.com) as saying. Marks is presumably acknowledging Vowst’s potential improvements over the late 2022 approval of Ferring Pharmaceuticals’ Rebyota (fecal microbiota) for preventing recurrent CDI, which is prepared from stool donated by qualified individuals, and then administered rectally as a single dose ([see earlier story](https://www.fdaweb.com/ferrings-fecal-microbiota-product-approved-for-c-diff/)).

CDI, which is caused by *C. difficile*, is a common healthcare-associated infection linked to 15,000 to 30,000 deaths annually, the (XXX INSERT XXX)agency says. The Vowst approved regimen is four capsules taken once a day. “Vowst contains live bacteria and is manufactured from human fecal matter that has been donated by qualified individuals,” it says. “Although the donors and donated stool are tested for a panel of transmissible pathogens, Vowst may carry a risk of transmitting infectious agents. It is also possible for Vowst to contain food allergens; the potential for Vowst to cause adverse reactions due to food allergens is unknown.”

Approval was based on data from a randomized, placebo-controlled clinical study that involved 89 participants who received Vowst and 93 that received placebo. “Through eight weeks after treatment, CDI recurrence in Vowst-treated participants was lower compared to placebo-treated participants (12.4% compared to 39.8%),” FDA says.