MTC Versus FMT in for RCDI
Part of paid clinical trials in New York, New York.
- Sponsor
- Icahn School of Medicine at Mount Sinai
- Study ID
- NCT05911997
- Phase
- PHASE1
- Status
- Recruiting
Conditions
- Clostridiodies Difficile Infections
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- MTC 01 — DRUGSlurry to be administered via colonoscopy
- Fecal Microbiota Transplantation (FMT) — DRUGStool from a healthy donor is blended with salt water and made into a liquid solution rich in bacteria. This solution is sprayed into the recipient's colon during a colonoscopy
Study Details
Investigating four different treatment of MTC or FMT
Key Dates
- Start date
- Jan 8, 2024
- Status verified
- Nov 2025
- Primary completion
- Jul 25, 2026
- Completion
- Jul 25, 2026
Study Design
- Enrollment
- 60 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- PREVENTION
Arms
- Experimental: High Dose MTC 01High dose MTC 01 is 10 x 11 CFU slurry to be administered via colonoscopy
- Experimental: Low Dose MTC 01Low Dose MTC 01 is 10 x 10 CFU slurry to be administered via colonoscopy
- Active Comparator: Low dose Fecal Microbiota Transplantation (FMT)High dose FMT is 10 x 11 CFU slurry to be administered via colonoscopy
- Experimental: High Dose Fecal Microbiota Transplantation (FMT)Low dose FMT is 10 x 10 CFU slurry to be administered via colonoscopy
Primary Outcome Measure
Number of treatment-related serious adverse events (SAE) as assessed by NIH grading [ Time Frame: up to 24 weeks ]
Central Contacts
- Sari Feldman, MS212-824-7669
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | Ari Grinspan (PRINCIPAL_INVESTIGATOR) |
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