Findings from a multicenter US study confirm that RBL is a safe and effective microbiota-based therapy with sustained remission in a high-risk population with comorbidities.
C difficile spores
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A real-world, multicenter study of 67 evaluable patients treated with fecal microbiota, live-jslm (Rebyota; RBL) demonstrated a 77.6% treatment success rate at 8 weeks for preventing recurrent Clostridioides difficile infection (rCDI), with 87% maintaining remission at 6 months. These findings support RBL’s safety and efficacy beyond controlled clinical trials in an older population with comorbidities frequently exposed to multiple rCDI risk factors.1
RBL achieved a 77.6% treatment success rate at 8 weeks and 87% sustained remission at 6 months in a high-risk, elderly population.
The treatment was well tolerated, with minor adverse events reported in only 5 patients.
Advanced age and multiple CDI recurrences were common risk factors, emphasizing the need for effective microbiota-based preventive strategies in these patients.
RBL, FDA approved in November 2022 as the first microbiota-based product for rCDI prevention in adults, is administered rectally after standard-of-care antibiotics. The study population had a median age of 74 years and a median Charlson comorbidity score of 4, with over half having 3 or more prior CDI recurrences. Risk factors were prevalent, including advanced age (72%), gastric acid suppressant use (55%), immunocompromise (24%), and recent non-CDI antibiotic exposure (21%).1
All patients received prior antibiotics, most commonly fidaxomicin (58%), before RBL administration. Adverse events were minimal, limited to minor leakage in 5 patients. Age of 65 years or more was significantly associated with higher recurrence risk. Among patients experiencing recurrence within 8 weeks, median time to relapse was 28 days. Of 30 patients with 6-month follow-up data, 26 (87%) sustained treatment response.1
These data provide important evidence for clinicians managing complex rCDI cases, highlighting RBL as a valuable and well-tolerated intervention to reduce recurrence risk in routine practice.1
In relation to RBL, in a recent interview with Paul Feuerstadt, MD, FACG, AGAF, he emphasized that beyond effectively reducing recurrent CDI, the treatment plays a crucial role in improving patients’ overall quality of life. Feuerstadt described how recurrent CDI often leads to significant anxiety, fear, and social isolation, likening the emotional burden to posttraumatic stress. He noted that RBL not only targets the infection but also helps restore patients’ mental, physical, and social well-being, allowing them to regain confidence and normalcy in their daily lives.2
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