On March 12, both FDA and OpenBiome, a nonprofit U.S. stool bank, issued announcements regarding the transmission of diarrheagenic E. coli in patients who were treated by fecal microbiota transplant (FMT) from three OpenBiome donors.
- Six patients experienced serious infections caused by enteropathogenic Escherichia coli (EPEC) and Shigatoxin-producing Escherichia coli (STEC). They have all since recovered.
- Following these reports, OpenBiome tested retained donor stool samples and confirmed the presence of these organisms in the product supplied to these six patients. The product came from three donors.
- All unused material from the infected donors was recalled and destroyed.
- In addition, two patients who received FMT product from the donor associated with the STEC infections died before the infections had been reported to either FDA or OpenBiome. Both were treated with FMT for C. difficile infection and had chronic medical conditions. It is unclear if STEC infection contributed to these deaths.
How this will impact FMT screening protocols:
- OpenBiome is immediately implementing enhancements to its screening program to ensure all FMT material is appropriately screened for these pathogens.
- OpenBiome is also working with FDA to implement retrospective screening of units to ensure that available material meets these new standards.
- FDA is further evaluating the procedures used for testing of donor stool used in the preparation of FMT products to determine the need for additional interventions.
What you can do:
- Continue to be diligent about donor screening and patient selection. FMT remains an investigational product, and patients should give informed consent after a frank discussion with you about potential benefits and risks, including potential transmission of multi-drug resistant and/or pathogenic organisms.
- Report any adverse events to FDA at 1-800-FDA-1088 or http://www.fda.gov/medwatch.
- Participate in the AGA FMT National Registry. Our goal is to track 4,000 patients for 10 years. The data we collect will allow us to identify potential short-term adverse outcomes and to search for long-term safety concerns. Please contribute to advancing the future of FMT — the information available to you and your patients at the end of this initiative will be worth it.
Colleen Kelly, MD, co-prinicipal investigator of the AGA FMT National Registry, provides more insights on this news in the AGA Community
The FMT National Registry is supported by the National Institute of Allergy and Infectious Diseases of the National Institutes of Health under Award Number R24AI118629.