Fecal microbiota, sold under the brand name, Rebyota is used for the prevention of recurrence of ''Clostridioides difficile'' infection. The most commonly reported adverse reactions include abdominal pain, diarrhea, abdominal distention, flatulence, and nausea. Fecal microbiota is prepared from stool donated by qualified individuals. The donors and the donated stool are tested for a panel of transmissible pathogens. Fecal microbiota is the first fecal microbiota product approved by the US

Food and Drug Administration The United States Food and Drug Administration (FDA or US FDA) is a List of United States federal agencies, federal agency of the United States Department of Health and Human Services, Department of Health and Human Services. The FDA is respon ...

(FDA). Fecal microbiota was approved for medical use in the United States in November 2022.

Medical uses

Fecal microbiota is approved for the prevention of recurrence of ''Clostridioides difficile'' infection (CDI) in people 18 years of age and older. It is for use after an individual has completed antibiotic treatment for recurrent CDI.

History

The safety of fecal microbiota 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 ''Clostridioides difficile'' infection. They received one or more doses of fecal microbiota or placebo 24 to 72 hours after completion of antibiotic treatment for their ''Clostridioides difficile'' infection; participants' ''Clostridioides difficile'' infection was under control at the time of receipt of fecal microbiota or placebo. Across these studies, 978 individuals aged 18 years and older received at least one dose of fecal microbiota. In one study, among 180 fecal microbiota recipients, when compared to 87 placebo recipients, the most common side effects after receiving one dose of fecal microbiota were abdominal pain, diarrhea, abdominal bloating, gas and nausea. The FDA granted the application for fecal microbiota, live fast track,

breakthrough therapy Breakthrough therapy is a United States Food and Drug Administration designation that expedites drug development that was created by Congress under Section 902 of the 9 July 2012 Food and Drug Administration Safety and Innovation Act. The FDA's "br ...

, and

orphan drug An orphan drug is a pharmaceutical agent developed to treat medical conditions which, because they are so rare, would not be profitable to produce without government assistance. The conditions are referred to as orphan diseases. The assignment of ...

designations. The FDA granted approval of Rebyota to Ferring Pharmaceuticals Inc.

Society and culture

Legal status

Fecal microbiota was approved for medical use in the United States in November 2022.

References

External links