The Food and Drug Administration has approved a fecal microbiota pill to treat recurrent infections caused by Clostridium difficile (C. diff), an antibiotic-resistant bacterium deemed an urgent threat to public health by federal health officials.
Vowst, made by Seres Therapeutics, Inc, is the first oral fecal microbiota product to be approved to prevent recurrence, the FDA announced Wednesday. It is indicated for patients aged 18 years and older following antibacterial treatment for repeat infections. In a clinical study, infection recurrence was lower in participants treated with Vowst (12%) when compared to placebo-treated participants (40%).
C. diff is one of the most common causes of healthcare-associated infections in the United States. It is estimated to be responsible for more than 100,000 infections among nursing homes residents each year. It is often recurrent and becomes more deadly with each repeat infection. People aged 65 years and older account for more than 80% of associated deaths, according to a study from the Centers for Disease Control and Prevention.
From colonoscopy to a pill
Fecal transplant therapy was widely recognized in western medicine as a treatment for C. diff in the 1970s and has gradually grown in use. It is typically given via colonoscopy after antibiotics fail to cure the recurring infection and has an overall success rate of 80% to 90%.
Vowst offers a new option for administering this treatment, the FDA noted. It is taken as four capsules once daily for three consecutive days.
“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,” said Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research.
The treatment does carry some risk, the FDA reported. It contains live bacteria from screened human donors and is tested for potential pathogens. Despite testing, infectious agents and food allergens could be present, with the possibility of causing other infections or adverse reactions.
An insidious infection
C. diff often multiplies when antibiotics taken for another infection kill protective organisms in the gut, leaving it vulnerable to infection. Patients can experience diarrhea, inflammation, abdominal pain and fever. Some patients with C. diff progress to organ failure and death.
C. diff is resistant to normal cleaning products and may last for months on surfaces. It can inadvertently be transmitted by contact among patients and healthcare providers.
Related articles:
Antibiotic overkill leads to widespread side effects such as C. diff, large study finds
New C. difficile treatment guidelines advise fidaxomicin over vancomycin (2021)
C. diff may sneak in on soles of shoes, sampling study shows
