15-strain live biotherapeutic product or same donor fecal microbiota transplant for recurrent Clostridioides difficile infection: a randomized phase 1b trial - PubMed
4 hours ago
- #Fecal Microbiota Transplant
- #Clostridioides difficile
- #Live Biotherapeutic Product
- The study introduces an accessible platform for producing human-grade live biotherapeutic products (LBPs) to accelerate their development.
- A randomized phase 1b trial directly compared a 15-strain LBP (MTC01) with fecal microbiota transplant (FMT) from the same donor for recurrent Clostridioides difficile infection (rCDI).
- Eighteen patients were randomized into four arms: low- and high-dose FMT, and low- and high-dose MTC01.
- The primary safety outcome was met, with adverse events evenly distributed and no treatment-related adverse events reported.
- Secondary efficacy outcomes showed similar prevention of rCDI at 8 weeks for both LBP (7 out of 9) and FMT (8 out of 9) patients.
- Strain engraftment was high and durable for both FMT and MTC01, with a dose effect observed for the LBP.