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Drug intelligence / Profile preview
biologically active human fecal material
- Development stage
- Phase 3
- Lead developer
- OpenBiome
- Modality
- Bacterial Strains → Single Strain Products → Live Biotherapeutic Products → Microbiome Therapeutics, Yeast Strains → Single Strain Products → Live Biotherapeutic Products → Microbiome Therapeutics, Defined Consortia → Multi-strain Products → Live Biotherapeutic Products → Microbiome Therapeutics, Complex Communities → Multi-strain Products → Live Biotherapeutic Products → Microbiome Therapeutics, Fresh FMT → Fecal Microbiota Transplantation (FMT) → Microbiome Therapeutics, Frozen FMT → Fecal Microbiota Transplantation (FMT) → Microbiome Therapeutics, Genetically Modified Bacteria → Engineered Microbial Therapeutics → Microbiome Therapeutics, Synthetic Biology Platforms → Engineered Microbial Therapeutics → Microbiome Therapeutics, Microbial Metabolites → Microbiome-Derived Products → Microbiome Therapeutics, Microbial Proteins → Microbiome-Derived Products → Microbiome Therapeutics
- Administration
- Rectal
01
Overview
Biologically active human fecal material is an investigational fecal microbiota transplant (FMT) product developed and supplied by OpenBiome, a nonprofit stool bank. It consists of pre-screened, tested, and quarantined human fecal material from healthy donors. The therapeutic works by restoring a healthy and diverse microbial community in the recipient's intestinal tract, thereby addressing dysbiosis associated with inflammatory bowel diseases. It has been primarily studied in a prospective, open-label pilot study (NCT02460705) led by the University of California, San Francisco (UCSF) for the treatment of ulcerative colitis. While it was also investigated for Crohn's disease, that arm of the study was halted for safety reasons. The material is typically administered as a 250 cc suspension via colonoscopy.
- Brand names
- BiomictraRebyotaVowst
- Other names
- fecal microbiota transplantFMTOpenBiome FMT
02
Targets
Dysbiotic colonic gut microbial communityPRR (Pattern recognition receptors)FFAR2
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