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MTC01

Development stage: Phase 1
Lead developer: Icahn School of Medicine
Modality: Synthetic Biology Platforms → Engineered Microbial Therapeutics → Microbiome Therapeutics, Fresh FMT → Fecal Microbiota Transplantation (FMT) → Microbiome Therapeutics, Yeast Strains → Single Strain Products → Live Biotherapeutic Products → Microbiome Therapeutics, Bacterial Strains → Single Strain Products → Live Biotherapeutic Products → Microbiome Therapeutics, Defined Consortia → Multi-strain Products → Live Biotherapeutic Products → Microbiome Therapeutics, Frozen FMT → Fecal Microbiota Transplantation (FMT) → Microbiome Therapeutics, Genetically Modified Bacteria → Engineered Microbial Therapeutics → Microbiome Therapeutics, Microbial Metabolites → Microbiome-Derived Products → Microbiome Therapeutics, Microbial Proteins → Microbiome-Derived Products → Microbiome Therapeutics, Complex Communities → Multi-strain Products → Live Biotherapeutic Products → Microbiome Therapeutics
Administration: Oral, Rectal

Overview

**MTC01** is an investigational, defined 15-strain live biotherapeutic product developed at Icahn School of Medicine at Mount Sinai for prevention of recurrent *Clostridioides difficile* infection. The product consists of bacterial strains isolated from a healthy-donor stool source and manufactured in vitro as a standardized microbial consortium intended to restore protective gut microbial functions and durably engraft in the recipient intestine. In a randomized phase 1b comparison with same-donor fecal microbiota transplantation, MTC01 showed comparable short-term safety and efficacy signals; it remains an unapproved investigational therapy. ([pmc.ncbi.nlm.nih.gov](https://pmc.ncbi.nlm.nih.gov/articles/PMC13444918/))

Other names: MTC 01MTC01MTC-01

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