FDA Approves Fecal Microbiota Product For Clostridioides difficle Infection Prevention
The FDA has approved a new fecal microbiota product to prevent the recurrence of Clostridioides difficle infection (CDI)—a potentially life-threatening disease caused by the bacterium. The treatment is the first product of its kind approved for adults by the FDA
The approval follows the results of three randomized, double-blind studies, where two determined the safety of the product, and the third established its effectiveness.
In the first two trials, participants involved in the studies (n = 978) had a history of one or more recurrences of CDI and were aged 18 years and older. Individuals received at least one dose of the fecal microbiota product or a placebo 24 to 72 hours after completing antibiotic treatment for CDI. In one of the trials, 180 participants received the fecal microbiota product, while 87 individuals received the placebo. When compared to the placebo group, those who received the product experienced abdominal pain, diarrhea, abdominal bloating, gas, and nausea—the most common adverse events after one dose.
In the last trial, the researchers compared the results of 177 participants who received one dose of the fecal microbiota product to 85 individuals who received one dose of placebo. The researchers defined the success of their study as the absence of CDI diarrhea within 8 weeks of a person receiving the fecal microbiota product. Additionally, the researchers used data from a different placebo-controlled study that compared the same product (n = 39) to placebo (n = 43). After their analysis, the researchers estimated the overall success rate in preventing CDI was higher in the fecal microbiota group (70.6%) than in the placebo group (57.5%).
“Recurrent CDI impacts an individual’s quality of life and can also potentially be life-threatening,” said Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, said in a press release. “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.”
FDA approves first fecal microbiota product. News release. US Food and Drug Administration; November 30, 2022. Accessed December 13, 2022. https://www.fda.gov/news-events/press-announcements/fda-approves-first-fecal-microbiota-product