Fecal transplant: FDA approves groundbreaking new treatment for colon infections

The product called Rebyota is manufactured from human feces.
Ayesha Gulzar
Intestinal microbiome
Intestinal microbiome.


The Food and Drug Administration (FDA) approved the first-ever fecal-based therapy to prevent the recurrence of Clostridioides difficile infection (CDI). The product, called Rebyota, is manufactured from human feces and works by repopulating the gut microbiome, thus preventing the bacteria from growing.

The therapy has been approved for people 18 years of age and older who have already completed antibiotic treatment for CDI.

Clostridioides difficile- the superbug

Clostridioides difficile is a bacterium that causes potentially life-threatening diarrhea and inflammation of the colon. It is usually a side effect of taking antibiotics long-term, which changes the balance of microorganisms in the gut. This allows the bacteria to grow and release toxins causing diarrhea, abdominal pain, fever, and in some cases, organ failure and death.

The infection can easily spread from person to person and occurs most often in people 65 and older who take antibiotics, those staying in hospitals and nursing homes for a long period of time, and in people with weakened immune systems.

The superbug is resistant to all but three current drugs and is associated with up to 30,000 deaths yearly in the U.S.

“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,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research.

Restoration of the gut microbiome

The newly approved therapy uses samples of microbes obtained from the stool of a healthy donor. Donors are tested for a range of transmissible pathogens. However, given the variability of fecal matter, there is a potential that it could contain an unforeseen infectious agent or food allergens, the FDA noted.

The therapy is administered through the rectum in one dose and works by restoring the gut microbiome, preventing the bacterial infection from growing and forcing it out of the gut.

Fecal transplant: FDA approves groundbreaking new treatment for colon infections
Bacteria growth in the small intestine.

The FDA approval of the Rebyota is based on combined data from randomized, double-blind, placebo-controlled clinical studies and open-label clinical studies conducted in the United States and Canada. The overall estimated success rate in preventing recurrent CDI through eight weeks was significantly higher in the Rebyota group (70.6%) than in the placebo group (57.5%).

Over 90% of subjects in the Rebyota group, who had treatment success, were found to be CDI recurrence-free for six months.

Safety of the fecal-based therapy

Safety was assessed in 2 randomized, double-blind, placebo-controlled clinical studies and three open-label clinical studies. A total of 978 adults received at least one dose of Rebyota. The most common adverse reactions reported with treatment included abdominal pain/distention, diarrhea, flatulence, and nausea.

Additionally, only mild-to-moderate adverse events (AEs) were reported in the trial, and there were no treatment-related serious adverse events (SAEs).

“Today’s announcement is not just a milestone for people living with recurrent C. difficile infection, but also represents a significant step which holds promise that many other diseases might be better understood, diagnosed, prevented, and treated using our rapidly evolving insights on the role of the microbiome in human health and disease,” said Per Falk, President, Ferring Pharmaceuticals, owner of the therapy.

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