Drug intelligence / Profile preview

rectal bacteriotherapy

Development stage
Phase 3
Lead developer
MT-MicroSearch
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

Rectal bacteriotherapy (RBT) is an investigational live biotherapeutic product developed as an alternative to fecal microbiota transplantation (FMT) for treating recurrent Clostridioides difficile infection (rCDI). [9, 11] It is composed of a standardized, laboratory-cultured mixture of a fixed number of intestinal bacterial strains (commonly 10 or 12) that were originally isolated from the feces of healthy donors. [2, 3, 14] Administered as a rectal enema, RBT aims to restore a healthy gut microbiome, which creates an environment that is resistant to C. difficile colonization and spore germination, thereby preventing infection recurrence. [2, 6] Clinical studies have compared RBT to standard-of-care antibiotics like vancomycin and to FMT, with results suggesting its efficacy is comparable to vancomycin but generally lower than that of FMT. [1, 8] The therapeutic approach was originally developed in Denmark by Dr. Tvede and Dr. Rask-Madsen. [2, 13]

Other names
fixed bacterial mixture12-strain bacterial mixture10-strain bacterial mixture

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