The death of a US patient from complications after a fecal transplant last week could have a major impact on microbiome research in Europe.
The microbiome is a field with big potential for treating disease by targeting imbalances in the patient’s gut flora, such as by giving patients the stool bacteria of a healthy person to target persistent infections such as Clostridium difficile.
Last week, the field suffered a setback after one patient died from a drug-resistant infection of Escherichia coli gained from a fecal transplant, prompting the FDA to suspend a number of similar clinical trials in the US. This event could also have an impact on the field in Europe as well.
“As it stands, it is not clear what impact this notification will have on the regulatory landscape for empirical fecal microbiota transplants,” James McIlroy, founder of UK microbiome biotech Enterobiotix, told me. This uncertainty also applies to microbiome treatments that are more controlled and targeted than fecal transplants.
What is clear for every organization researching microbiome-based treatments is that fecal microbiota transplants must be screened very thoroughly before being given to patients.
All risks considered, fecal transplants have cleared up to 90% of C. difficile infections in clinical trials, and have the potential to treat other conditions such as inflammatory bowel disease. “Assuming that donors have been rigorously screened, fecal microbiota transplants appear to be safe and well tolerated in the short term, with the majority of side effects being mild and gastrointestinal in nature,” McIlroy said.
A consortium of companies including the French biotech MaaT Pharma and Enterobiotix was launched last month to make recommendations on how the EU regulates various treatments centered around the microbiome. In particular, the consortium aims to standardize the EU regulatory process for microbiome-based treatments that are produced industrially, making them more standardized and controllable than fecal transplants.
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