Real-World Data Reinforce Effectiveness and Safety of Fecal Microbiota Therapy for Preventing Recurrent C. difficile

The latest findings from the ongoing ROAR registry (NCT05835219) provide compelling real-world evidence that the fecal microbiota product fecal microbiota, live‑jslm (also known by the brand name RBL) continues to demonstrate both high effectiveness and a favorable safety profile in preventing recurrent Clostridioides difficile infection (rCDI) among adults in US everyday clinical settings.

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Study Context

Fecal microbiota, live-jslm is an FDA-approved treatment for preventing rCDI in adults after they have completed antibiotic therapy for C. difficile infection. The ROAR registry is a prospective, multicenter, open-label, non-interventional study designed to assess how the therapy performs beyond the controlled environment of clinical trials.

Eligible participants are adults who finished antibiotic treatment for rCDI and are not taking part in any interventional trials. The primary endpoint is treatment success, defined as no recurrence of CDI within eight weeks after therapy.

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Key Findings

• Among 76 patients who completed eight-week follow-up (median age 69 years, range 19–96; 76.3% female; 93.4% White) the treatment success rate was 82.9% (63 / 76) (95% CI, 72.5%–90.6%)
• Subgroup analysis showed success rates ranged from 77% to 100% depending on age groups and number of prior CDI episodes, indicating consistent efficacy across diverse patient profiles.
• Interestingly, patients with an antibiotic wash-out period longer than 72 hours experienced an even higher success rate of 87.8%.
• Adverse events (AEs) were recorded in 18 patients (23.7%), with six serious AEs (7.9%) and one event of special interest (large-bowel obstruction, 1.3%). Only three AEs (3.9%) were considered treatment-related, and one death occurred but was deemed unrelated to the therapy.

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Implications for Practice

The ROAR registry data reinforce that fecal microbiota, live-jslm is both effective and well-tolerated when applied in real-world clinical practice. The high rate of treatment success (82.9%) parallels results seen in earlier clinical trials, supporting broader adoption of this therapy in patients with rCDI. Moreover, the low incidence of treatment-related adverse events adds confidence to its safety profile.

For clinicians managing rCDI, these findings suggest that:

• Early consideration of fecal-microbiota therapy post-antibiotics may help reduce recurrence.
• Monitoring the antibiotic wash-out timing might optimise outcomes (as suggested by higher success with >72-h wash-out).
• Diverse patient populations (including older adults and those with multiple prior recurrences) may still benefit substantially.

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Limitations & Considerations

As with any real-world registry, certain limitations require attention:

• The sample size is relatively small (76 patients) and the demographic skew (76% female, >90% White) may limit generalisability.
• Follow-up duration was eight weeks — longer-term outcomes and sustained prevention beyond this period remain less well characterised.
• Being an open-label, non-interventional study, there may be inherent biases in patient selection and data capture.

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Outlook

The next steps for the field will include expansion of registry datasets (with broader demographics and longer follow-up), head-to-head comparisons with other therapies, and exploration of optimisation strategies (e.g., timing, pre-treatment optimisation) for fecal-microbiota therapy. For now, the real-world evidence supports its role as a key option in preventing rCDI.

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