Clinical trials indicate success but there are risks and many unknowns in the novel therapy
Patients needing a fecal microbiota transplant for recurrent Clostridioides difficile (C. diff) infections now have the option of getting stool in pill form.
The U.S. Food and Drug Administration (FDA) recently approved Vowst, the first oral biologic drug for fecal microbiota that was shown in clinical trials to be as effective as fecal microbiota transplants given rectally. Biologic drugs are derived from blood, proteins, bacteria, and other living organisms.
In a traditional fecal microbiota transplant or FMT, healthy donor stool is transferred into the colon of a patient, usually via colonoscopy or retention enema. Late last year, the FDA approved the first microbiota product for rectal administration to C. diff patients.
C. diff, often contracted by taking antibiotics, is highly a contagious bacterial infection that causes severe diarrhea, abdominal pain, and fever and can result in organ failure and even death. Recurrent infections within two to eight weeks are a problem for about one in six patients, according to the U.S. Centers for Disease Control and Prevention (CDC). Risk factors include recent hospital or nursing home stay, a weakened immune system, and previous C. diff infections.
In response to the approval of the new oral microbiota product, Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said in a news release:
“The availability of a fecal microbiota product that can be taken orally is a significant step forward in advancing patient care and accessibility for individuals who have experienced this disease that can be potentially life-threatening.”
New Product, New Risks
Vowst—taken as a dose of four capsules for three consecutive days—is not free of risk. The donated human fecal matter is screened for transmissible pathogens before it is manufactured. However, as the news release pointed out, there is a possibility that donor stool used in the pill could be infected with infectious pathogens, as well as food allergens. The potential for adverse reactions caused by Vowst due to such allergens is unknown.
By Amy Denney
