A multicenter US study confirms that RBL is a safe and effective microbiota-based therapy with sustained remission in a high-risk, comorbid population.
C diff spores
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A real-world, multicenter study of 67 evaluable patients treated with fecal microbiota, live-jslm (RBL), demonstrated a 77.6% treatment success rate at 8 weeks for preventing recurrent Clostridioides difficile infection (rCDI), with 87% maintaining remission at six months. These findings support RBL’s safety and efficacy beyond controlled clinical trials in an elderly, comorbid population 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 three 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 ≥65 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 Clostridioides difficile infections, 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 post-traumatic 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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