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MITI-001

Development stage: Phase 1
Lead developer: Stanford University
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

Overview

MITI-001 is an investigational, donor-stool-derived defined gut bacterial consortium developed by Stanford University for diarrhea-predominant irritable bowel syndrome. The product contains 157 purified, banked live bacterial strains spanning 79 commensal genera. It is intended to correct microbiome dysfunction and restore microbial metabolic functions, including bile acid metabolism, in a subset of patients with irritable bowel syndrome with diarrhea. MITI-001 is being evaluated in a Phase 1 safety study, NCT07238790. ([clinicaltrials.stanford.edu](https://clinicaltrials.stanford.edu/trials/u/NCT07238790.html))

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