First faecal transplant treatment approved for use in the US

The person is Grace Wade.

The FDA approved Rebyota as the first faecal transplant product. The treatment uses human stool to prevent infections in adults.

Between 15,000 and 30,000 people in the US die each year from Clostridium difficile, a disease caused by antibiotics. There are a number of symptoms, including abdominal pain and organ failure. There are limited treatment options for recurrent infections after a first C. difficile.

A single dose of Rebyota is given through the rectum. Human stool can be used to restore the balance ofbacteria in the gut of people who have already been treated for the disease.

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In an eight-week trial of 262 adults with recurrent CDI, Rebyota prevented future infections in 71 percent of cases, whereas the same was true for less than 58 percent of those who received a placebo.

According to the FDA, there is a risk of infections with Rebyota, even though donors and their stool are screened for pathogens. The FDA said that it is not certain if this could cause an allergic reaction.

Peter Marks, the director of the FDA's Center for Biologics Evaluation and Research, said in a news release that today's action is an important milestone.

The FDA doesn't regulate faecal transplants unless donors and the stool they use are screened for infectious diseases.

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