The US Food and Drug Administration (FDA) has approved the first pharmaceutical version of the so-called fecal transplant procedure, which doctors have increasingly used against difficult-to-treat intestinal infections.
The drug, Rebyota, is designed for adults infected with Clostridium difficile, commonly known as C. diff, a bacterium that causes nausea, cramps and diarrhea.
Peter Marks, director of the FDA’s Center for Biological Research and Evaluation, called the approval “an important milestone” that provides another option in the fight against recurrent C. diff infection.
Fecal microbiota transplantation (FMT) involves the transplantation of feces from a healthy individual into the intestinal tract of a diseased recipient to restore the microbial composition of the intestine after illness or infection when the patient does not respond to antibiotics.
Serious infections caused by bacteria resistant to commonly used antibiotics are a great challenge to modern healthcare. This reality has led professionals to increasingly resort to alternative practices to combat the disease.
Research has shown The human microbiota, estimated to contain between 10 and 100 trillion microbial cells, plays an important role in maintaining our overall health and well-being, both physically and psychologically.
How does the fecal microbiota transplant work?
The fecal transplant recipient usually chooses the donor, and most people choose a close friend or family member.
A sample is then tested for possible pathogens, and if it is removed, the therapy is administered via the rectum by healthcare professionals as a single procedure.
The first known description of the use of feces as a therapy was described by Ge Hong, a renowned Chinese alchemist, in the 4th century for the treatment of a variety of conditions including diarrhea and food poisoning.
In the last decade, patients have become increasingly resistant to antibiotics, and medical research on the human microbe has experienced significant growth. Doctors in the United States have reportedly turned to the FMT technique more frequently.
In parallel, the proliferation of stool banks and fecal transplant professionals across the country has created regulatory headaches for the FDA, which traditionally does not regulate physicians’ medical procedures.
Now, for the first time, it has given the green light for a stool-based microbial therapy to prevent recurrent and life-threatening forms of C. diff infection.
A pharmaceutical version of the fecal transplant
On Wednesday, the FDA approved Ferring Pharmaceuticals’ Rebyota for use in patients older than 18 years after unsuccessful antibiotic treatment.
Rebyota contains a controlled cocktail of healthy microbiota, made from donated feces, and has been shown to be effective against C. diff in adults.
C. diff infection is cited by the Centers for Disease Control and Prevention as an urgent public health threat, responsible for nearly half a million infections each year in the US alone and nearly 30,000 associated deaths.
Symptoms of C. diff, which is more common in older people and people with weakened immune systems, include severe diarrhea, fever, stomach tenderness or pain, loss of appetite, nausea, and colitis.
Ferring Pharmaceuticals, the Swiss company behind the new drug, is one of many players working to develop new microbiome-based therapies and explore the crucial link between the microbiome and human health.