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MBiotix HBI

Development stage
Phase 3
Lead developer
Human Biome Institute
Modality
Live Biotherapeutic Products → Microbiome Therapeutics
Administration
Intraduodenal, Intragastric, Intrajejunal, Gastroscope, Colonoscope, Peg Tube, Rectal Enema
01

Overview

**MBiotix HBI** is a donor-derived, high-richness, high-diversity, high-viability fecal microbiota suspension developed by Human Biome Institute for fecal microbiota transplantation (FMT). It is administered via intraduodenal, intragastric, intrajejunal tubes, gastroscope, colonoscope, PEG tube, or rectal enema, containing approximately 10^13 bacterial cells comparable to those in the human large intestine. Primarily indicated for recurrent **Clostridioides difficile** infections (CDI) with over 90% efficacy matching global standards, it restores gut microbiota balance and is also explored in antibiotic-resistant bacteria (ARB) decolonization, graft-versus-host disease (GvHD), inflammatory bowel disease (IBD), and chronic diarrhea cases post-transplant or immunosuppression. Produced under anaerobic conditions with rigorous donor screening, molecular, microbiological, and cytometric quality controls approximating GMP standards.[1][3][4][5][8][10][14]

Brand names
MBiotix HBI
Other names
Mbiotix HBI

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