Fecal microbiota, live-jslm (RBL) continues to demonstrate robust real-world performance. While RBL’s safety and efficacy were previously established in clinical trials, the ROAR registry (NCT05835219) is providing important insight into its outcomes in everyday clinical settings.
RBL is an FDA-approved therapy for the prevention of recurrent Clostridioides difficile infection (rCDI) in adults following antibiotic treatment,
About the Study
ROAR is an ongoing, prospective, multicenter, open-label, non-interventional study evaluating RBL’s effectiveness in preventing rCDI recurrence through eight weeks post-treatment. Eligible participants are adults who completed antibiotics for rCDI and are not enrolled in any interventional trials. The study’s primary endpoint measures treatment success—defined as the absence of CDI recurrence within eight weeks.
What You Need to Know
In the ROAR registry, 82.9% of patients treated with fecal microbiota, live-jslm (RBL), experienced no recurrence of C difficile infection through eight weeks, confirming RBL’s effectiveness outside of clinical trials.
Treatment success remained high—ranging from 77% to 100%—across different age groups and numbers of prior CDI episodes, suggesting broad applicability in diverse patient populations.
Adverse events were infrequent and mostly unrelated to treatment, supporting RBL’s continued safety in routine clinical use.
As of September 18, 2024, 76 patients had received RBL within 30 days of completing antibiotic therapy and completed eight weeks of follow-up. The median patient age was 69 years (range 19–96), and most were female (76.3%) and White (93.4%). Overall, 82.9% (63/76) of participants achieved treatment success (95% CI, 72.5%–90.6%). Among those with an antibiotic washout period longer than 72 hours, success rates were even higher at 87.8%. Consistent treatment success was observed across subgroups stratified by age and previous CDI episodes.
Adverse events (AEs) were reported in 18 patients (23.7%), including six serious AEs (7.9%) and one event of special interest (large bowel obstruction, 1.3%). Only 3 AEs (3.9%) were considered related to RBL, and one death occurred during the study but was deemed unrelated to treatment.
These initial findings align with prior clinical trial data, reinforcing that RBL is both effective and well-tolerated for preventing recurrent C difficile infection in real-world practice.
Reference
1. Van Hise N, et al. Initial Results From a Real-World Patient Registry Study of Adults Receiving Fecal Microbiota, Live-jslm for the Prevention of Recurrent Clostridioides difficile Infection: The RebyOtA Prospective Registry (ROAR). Presented at IDWeek 2025. October 19-22, 2025. Atlanta, GA.
