Background: Faecal microbiota transplantation (FMT) is a highly effective treatment for Clostridioides difficile infection. Its use is backed by solid evidence, but application methods differ. Encapsulated FMT is a non-invasive, patient-friendly and scalable application method that may be preferred over colonoscopy or nasoduodenal tube application.
Objectives: We describe a detailed protocol, the Glyprotect protocol, for producing glycerol-based capsules to increase FMT accessibility.
Design: Using iterative quality improvement methods, we developed and validated the Glyprotect protocol as a reproducible protocol for cryopreserving minimally processed donor faeces in a standard hospital laboratory setting.
Methods: We describe detailed standard operating procedures for producing glycerol-based capsules, including all necessary materials and troubleshooting guidelines. Capsule integrity was tested at various temperatures and pH levels. Flow cytometry was used to measure microbiota counts and dose accuracy.
Results: The Glyprotect protocol has been used for more than 2500 capsule-based FMT treatments and complies with European tissue and cell standards. The protocol is optimised to preserve microbes and minimise modulation of the donated microbiota by removing debris and water, which also reduces the number of capsules needed per FMT treatment. The intestinal microbiota is preserved in glycerol for cryoprotection and to prevent capsule leakage. Each capsule contains 650 µL microbe-glycerol mass, estimated to contain an average of 2.5 × 108 non-specified bacteria.
Conclusion: The Glyprotect protocol enables hospitals and tissue establishments to set up capsule production in a standard laboratory, improving patients' access to FMT. The protocol facilitates the scalability of FMT services because capsule FMT is less time-consuming and less expensive than liquid-suspension FMT applied by colonoscopy or nasojejunal tube.
Trial registration: Not applicable.
Keywords: Clostridioides difficile; capsules; clinical laboratory techniques; faecal microbiota transplantation; laboratory manual [publication type]; medical laboratory personnel; microbiology; patient safety.
A protocol for production of encapsulated donor faeces for faecal microbiota transplantation We provide a detailed description of how to produce encapsulated donor faeces for faecal microbiota transplantation (FMT). FMT is a highly effective treatment for diseases where the intestinal microbiota is compromised, in particular Clostridioides difficile infection. Encapsulated application is patient-friendly and non-invasive, but protocols for the production of FMT capsules have not been published or are not reproducible. We here provide detailed guidance for standard-equipped hospital laboratories to enable capsule production under the current regulatory framework for substances of human origin in Europe. The dissemination of this protocol will increase patients’ access to a life-saving therapy.
© The Author(s), 2024.