FDA Approves First Fecal Microbiota Product


News Release, International Society of Microbiota, France – December 2, 2022

Today, the U.S. Food and Drug Administration approved Rebyota, the first fecal microbiota product approved by the agency. Rebyota is approved for the prevention of recurrence of Clostridioides difficile infection (CDI) in individuals 18 years of age and older. It is for use after an individual has completed antibiotic treatment for recurrent CDI.

“Today’s approval of Rebyota is an advance in caring for patients who have recurrent C. difficile infection,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research. “Recurrent CDI impacts an individual’s quality of life and can also potentially be life-threatening. As the first FDA-approved fecal microbiota product, today’s action represents an important milestone, as it provides an additional approved option to prevent recurrent CDI.”

Clostridioides difficile (C. difficile) is a bacterium that can cause CDI, a potentially life-threatening disease resulting in diarrhea and significant inflammation of the colon. In the United States, CDI is associated with 15,000-30,000 deaths annually.  

The intestinal tract contains millions of microorganisms, often referred to as the “gut flora," or "gut microbiome." Certain situations, such as taking antibiotics to treat an infection, may change the balance of microorganisms in the gut, allowing C. difficile to multiply and release toxins causing diarrhea, abdominal pain and fever, and in some cases, organ failure and death. Other factors that can increase the risk for CDI include age older than 65 years, hospitalization, a weakened immune system and a previous history of CDI. After recovering from CDI, individuals may get the infection again—often multiple times—a condition known as recurrent CDI. The risk of additional recurrences increases with each infection and treatment options for recurrent CDI are limited. The administration of fecal microbiota is thought to facilitate restoration of the gut flora to prevent further episodes of CDI.

Rebyota is administered rectally as a single dose. Rebyota is prepared from stool donated by qualified individuals. The donors and the donated stool are tested for a panel of transmissible pathogens, however, as Rebyota is manufactured from human fecal matter, it may carry a risk of transmitting infectious agents. In addition, Rebyota may contain food allergens; the potential for the product to cause adverse reactions due to food allergens is unknown.

The safety of Rebyota was assessed from two randomized, double-blind, placebo-controlled clinical studies and from open-label clinical studies conducted in the United States and in Canada. The participants had a history of one or more recurrences of CDI. They received one or more doses of Rebyota or placebo 24 to 72 hours after completion of antibiotic treatment for their CDI; participants' CDI was under control at the time of receipt of Rebyota or placebo. Across these studies, 978 individuals aged 18 years and older received at least one dose of Rebyota. In one study, among 180 Rebyota recipients, when compared to 87 placebo recipients, the most common side effects after receiving one dose of Rebyota were abdominal pain, diarrhea, abdominal bloating, gas and nausea.

The effectiveness of Rebyota was evaluated in an analysis of data from a randomized, double-blind, placebo-controlled, multicenter study. The analysis included 177 adults who received one dose of Rebyota and 85 who received one dose of placebo in this study. It also incorporated success rates from a different placebo-controlled study in which 39 adults received one dose of Rebyota and one dose of placebo and 43 adults received two doses of placebo. Success in preventing recurrent CDI was defined as the absence of CDI diarrhea within 8 weeks of administration of Rebyota or placebo. In a statistical analysis that took into account both studies, the overall estimated rate of success in preventing recurrent CDI through 8 weeks was significantly higher in the Rebyota group (70.6%) than in the placebo group (57.5%).

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International Society of Microbiota


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