The clinical opportunity that microbiome-based therapeutics represents has fecal microbiota transplant (FMT) as a starting point. A dysbiotic microbiome has been linked to multiple diseases including:
- Primary C. difficile infection (CDI)
- Other infectious diseases
- Inflammatory bowel disease (IBD)
- Irritable bowel syndrome (IBS)
- Metabolic diseases
- Other indications (e.g., CNS, cancer)
While FMT works, a better approach is needed as the widespread adoption of FMT is problematic. FMT is a procedure, not a product. FMT is a true transplant of human-derived biological material: risks of infection transmission can't be fully resolved. Additionally, there is poor patient and health care worker acceptance. Finally, there is batch to batch inconsistency.
What success in replacing FMT looks like: an oral "biologic" pill with efficacy that meets or exceeds the response seen with FMT.
The Human Microbiome Project
The International Human Microbiome Consortium
American Gastroenterological Association
American Society for Microbiology FAQ: Human Microbiome
National Public Radio coverage
Clostridium difficile Infection