May 23, 2025
By John Parkinson
PAUL FEUERSTADT, MD, FACG, AGAF’
Paul Feuerstadt, MD, discuses the treatment’s overall safety and efficacy profile and provides insights on data around smaller subsets of patients with comorbidities.
Fecal microbiota, live-jslm (Rebyota [RBL]), which is indicated for treatment of recurrent C difficile, has been FDA approved for over 2 years now, and with it comes real-world efficacy and safety data.
Paul Feuerstadt, MD, FACG, AGAF, associate clinical professor of Medicine at Yale School of Medicine, has been involved with studies around this therapy for several years, and believes the product is very safe and effective.
He provides details about an abstract presented at the Digestive Disease Week conference that looked at 5 prospective trials, including 2 randomized control trials and multiple open label studies. “It was an integrated safety analysis of those trials, including 11,192 individuals who received at least of 1 dose of RBL, 676 who received 1 dose of RBL, and 83 who received placebo. And then in effect, showed that there was consistency of adverse events between the placebo and those who received RBL, and that consistency shows that RBL doesn’t leave patients at greater risk for adverse events and serious adverse events,” Feuerstadt said. “Serious adverse events were 11.2% for a single dose of RBL, and 7.2% for a single dose of placebo.”
