Lukas Bethlehem, Former Scientist PharmaBiome AG, shared a post on LinkedIn:
“Deeply honored to share that our work has been published in Nature Medicine (Nature Portfolio):
“15-strain live biotherapeutic product or same-donor fecal microbiota transplant for recurrent Clostridioides difficile infection: a randomized phase 1b trial”
Full Article: here.
DOI: 10.1038/s41591-026-04442-2
We present a new platform for manufacturing defined microbial consortia that is affordable, and safe for use in human microbiome clinical trials. To accelerate the field, we are openly sharing the full regulatory (IND) and microbial consortia documentation alongside the publication — because we believe a broad clinical foundation will bolster trust, investment and regulatory clarity for the field.
In a first-of-its-kind randomized clinical trial, we directly compared an in vitro-manufactured defined microbial consortium (MTC01) to its matched donor fecal microbiota transplant (FMT) from the same donor. The result: bacterial strains manufactured with our platform retain their efficacy in treating recurrent C. difficile infection (rCDI). Defined products like MTC01 offer clear advantages over undefined FMT — including a defined safety profile and consistent, reproducible efficacy.
Trial outcomes at a glance:
- Safety: No treatment-related adverse events among 18 patients
- Efficacy: rCDI prevention in 7/9 MTC01 and 8/9 FMT patients
- Engraftment: High and durable for both treatments; most reliable for MTC01 at high dose
Are you interested in safely and affordably translating a microbiota therapeutic to the clinic? Fill in the form in the comments or reach out to me directly.
I am actively scouting for institutions in Europe to establish a translational center with our platform.
A heartfelt thank you to the entire team at the Icahn School of Medicine at Mount Sinai and our partners at Massachusetts General Hospital and Duke University Health System for making this vision a reality. And a special acknowledgment to Jeremiah Faith — an exceptional leader and mentor.
Related content:
Here. Here. and Here.”
Title: 15-strain live biotherapeutic product or same-donor fecal microbiota transplant for recurrent Clostridioides difficile infection: a randomized phase 1b trial”
Authors: Lukas Bethlehem, Lorenza Bartu, Gina Marke, Phyu Mar, Sari Feldman, Joseph Eggers, Constantin Ruprecht, Graham J. Britton, Varun Aggarwala, Gerold Bongers, Zhihua Li, Nancy Yang, Elizabeth L. Hohmann, Ilaria Mogno, Jeremiah J. Faith, Ari Grinspan
Read the article: here.
Other articles featuring Lukas Bethlehem on Oncodaily.