Several microbiota-based live biotherapeutic products (LBPs) have now completed phase 2 and 3 clinical trials and appear to offer a therapeutic advance for the management of recurrent Clostridioides difficile infection (rCDI). The long-term outcomes of these therapies are only now being described.

Data were recently published from a phase 2 safety and efficacy study of RBX2660, as a treatment for patients with ≥ 2 previous rCDI episodes who had completed standard-of-care antibiotic therapy, or severe CDI requiring hospitalization. RBX2660 was 79% successful in preventing recurrence of CDI at 8 weeks.

More than 90% of patients treated with RBX2660 who had treatment success at 8 weeks continued to be CDI-free at 6, 12, and 24 months.

The gut microbiota in patients who had treatment success were restored from dysbiosis, became more diverse and more similar to RBX2660 composition, and reflected a healthier microbiome to that observed prior to RBX2660 administration.

Based on the clinical trial data, LBPs will most likely benefit those who have had ≥ 1 rCDI episode or those who are at high risk of rCDI after an initial episode.