15-Strain Live Biotherapeutic Product Compared With Same-Donor FMT For rCDI

Key Takeaways

• Short-term recurrence prevention was reported in both the manufactured product group and the same-donor FMT group at 8 weeks after dosing.
• The prespecified primary safety outcome was met, and no treatment-related adverse events were reported.
• Strain engraftment was reported as high and durable in both groups, with a dose effect observed for MTC01.

In a phase 1b trial in recurrent Clostridioides difficile infection, seven of nine patients given the 15-strain live biotherapeutic product MTC01 remained free of recurrence at 8 weeks after dosing, compared with eight of nine patients given same-donor fecal microbiota transplant. The trial compared a donor-sourced same-donor fecal microbiota transplant with an in vitro manufactured 15-strain product derived from the same bacterial strains. Both approaches were evaluated in low- and high-dose groups, with recurrence prevention listed among the secondary outcomes at 8 weeks. The text also reported safety and strain engraftment findings from the small randomized cohort.

This phase 1b randomized controlled trial enrolled 18 of 20 screened patients who met eligibility criteria and were randomized equally across four arms. The groups were low-dose FMT (n=4), high-dose FMT (n=5), low-dose MTC01 (n=4), and high-dose MTC01 (n=5). Among randomized participants, the female-to-male ratio was 5:1. The study was a single-blind, parallel-group comparison, with nine participants assigned to FMT and nine to MTC01. Investigators described the trial as a direct comparison of donor-sourced FMT with a manufactured product containing the same strains.

The prespecified primary safety outcome was met, with 10 adverse events recorded across eight patients in the available report. Adverse events occurred in eight of the 18 randomized patients who received study treatment. The distribution was even by treatment type, with five events among MTC01 recipients and five among FMT recipients. No treatment-related adverse events were reported across all four groups.

Secondary outcomes included efficacy and engraftment, with most patients in both treatment groups remaining recurrence-free at 8 weeks after dosing. Strain engraftment was described as high and durable with both FMT and MTC01 across the reported follow-up window. A dose effect was reported for the live biotherapeutic product.