FDA Alert

First Oral Treatment to Prevent Recurring Clostridioides difficile Infection Approved

Jessica Ganga

The FDA has approved the first fecal microbiota product for the prevention of recurring Clostridioides difficile (C. difficile) infection (CDI). The oral treatment is approved for individuals aged 18 years and older, following antibacterial treatment for recurrent CDI.

“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,” Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, said in a press release.

CDI is one of the most common healthcare-associated infections in the United States that is caused by the bacterium C. difficile. According to the FDA’s press release, the infection causes 15,000 to 30,000 deaths annually.

The approval follows a randomized, double-blind, placebo-controlled clinical study and an open-label clinical study—both tested on the safety of the treatment. Across both studies, participants (n = 346) had recurrent CDI, were 48 to 96 hours post-antibacterial treatment, and their symptoms were controlled. In an analysis among 90 oral treatment recipients, when compared to 92 placebo recipients, the most common adverse events were abdominal bloating, fatigue, constipation, chills, and diarrhea.

Further, the efficacy of the oral treatment was evaluated in the randomized, placebo-controlled clinical study. Participants received either the oral treatment (n = 89) or placebo (n = 93) during 8 weeks of treatment. At the end of the 8th week, CDI recurrence in the oral treatment group was lower when compared to those that received placebo (12.4% compared to 39.8%).

Patients should follow the dosing regimen of four capsules taken once a day, orally, for three straight days. The oral treatment contains live bacteria and is manufactured from human fecal matter that has been donated by those qualified to do so. While the donors and donated stool are tested for several different transmissible pathogens, the medication may still carry a risk of transmitting infectious agents and/or may contain food allergens.



FDA approves first orally administered fecal microbiota product for the prevention of recurrence of Clostridioides difficile Infection. News release. US Food and Drug Administration; April 26, 2023. Accessed May 31, 2023.