Making standardized live bacterial medicines for C. difficile and gut inflammation
Official title: Manufacture of defined live microbial therapeutics for infectious and inflammatory disease
Funded at Icahn School of Medicine at Mount Sinai · NIH-11261767 · Data updated 2026-11-12
Developing reliable ways to produce live bacterial medicines that can replace donor stool for people with recurrent C. difficile and other gut inflammation.
Quick facts
| Grant type | R01 grant |
|---|---|
| Study type | NIH-funded research |
| Funding institution | Icahn School of Medicine at Mount Sinai NIH-funded |
| Lab location | 1 site (New York, United States) |
| Project start | February 1, 2025 |
| Project end | January 31, 2029 |
| Funding year | 2026 |
| Award (this year) | $671,511 |
| NIH project number | 5R01DK141891-02 |
| Project ID | NIH-11261767 on NIH RePORTER |
Who could benefit from this research
✓Could help
Adults with recurrent Clostridioides difficile infection who meet clinical trial criteria and are willing to enroll at a participating site would be the most likely candidates.
✕Less likely to help
People without C. difficile infection, or those with medical conditions that exclude them from clinical trials (for example certain severe immunosuppression), are unlikely to benefit from this specific effort.
What this research studies
This project focuses on turning promising donor-derived stool therapies into defined, made-in-a-lab bacterial medicines that are safer and easier to scale. The team created a 15-strain product called MTC01 taken from a previously successful stool donor and is manufacturing those strains on animal-free media. MTC01 is already being compared with donor stool in an early human trial, while the grant work aims to improve how these bacteria are grown and produced so more patients could access them. From a patient viewpoint, this could mean more consistent treatments without relying on stool donations.
Why it matters
Potential benefit: If successful, this work could provide a safer, more consistent, and widely available alternative to fecal transplants for recurrent C. difficile and related gut conditions.
How similar studies have gone: Two fecal-based products have been approved for rCDI and early-phase trials of defined live biotherapeutics like MTC01 are already underway, showing promising but still early results.
Where this research is happening
-
Icahn School of Medicine at Mount Sinai
New York, United States Active
Researchers
- Principal investigator: Faith, Jeremiah James — Icahn School of Medicine at Mount Sinai
- Study coordinator: Faith, Jeremiah James
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About this research
- This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
- Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
- For full project details, budget, and progress reports, visit the official NIH RePORTER page.