How to: Establish and run a stool bank.
WTF News: Long and full of science babble. But the source site is 5x longer at least.
Since 2013, several stool banks have been developed following publications reporting on clinical success of ‘faecal microbiota transplantation’ (FMT) for recurrent Clostridium difficile infections (CDI). However, protocols for donor screening, faecal suspension preparation, and transfer of the faecal suspension differ between countries and institutions. Moreover, no European consensus exists regarding the legislative aspects of the faecal suspension product. Internationally standardized recommendations about the above mentioned aspects have not yet been established.
The overall and primary aim of a stool bank is to provide on a (inter)national or regional level, ready to use, high-quality donor faeces solutions to treat patients with recurrent or refractory CDI. Fecal microbiota transplantation (FMT) is a recommended therapy for recurrent Clostridioides difficile infection and is being investigated as a potential therapy for dozens of microbiota-mediated indications. Stool banks centralize FMT donor screening and FMT material preparation with the goal of expanding access to FMT material while simultaneously improving its safety, quality, and convenience.
As FMT is not yet an approved, treatment modality by the European Medicines Agency (EMA) or US Food and Drug Administration (FDA), commercial stool banks are not the preferred suppliers. A stool bank working group should consist of experts in the fields of microbiology, infectious diseases, gastroenterology, biobanking, and methodology, and if donor faeces is considered to be a drug, pharmacology. There are published consensuses on donor screening guidelines, there are few reports about the implementation of those guidelines in functioning stool banks.
In 2018, the stool bank received 7,536 stool donations from 210 donors, a daily average of 20.6 donations, and processed 4,271 of those donations into FMT preparations. It is generally believed that a high viability of bacteria in stools increases the chance of successful FMT. As the majority of faecal bacteria are anaerobic, faeces must be processed within 6 hours of defecation [
To prevent environmental contamination, faeces is collected by the donor in a faecal container (e.g. Fecotainer). For suspension, approximately 60 g of donor faeces is used based on the data of a systematic review suggesting a decreased cure rate with <50 g. The faeces is homogenized with saline using a mortar and pestle, whereas some laboratories use a commercial blender. Disadvantages of blenders are difficulties with appropriate sterilization and aerosolization of the faeces.
A metal sieve (mesh 300 μm) is used to remove undigested food fragments. The faecal suspension is then concentrated by centrifugation (15 min, 6000 g) and glycerol is added as cryoprotectant to a final concentration of 10% in a total end volume of 200 mL. A recent study showed that frozen faecal suspension is equally effective as a fresh faecal suspension for the treatment of CDI.
This allows stool samples to be stored at −80°C for a longer period of time until the donor has been retested prior to actual use of the donor faeces. Clinical success of frozen suspensions is reported until 5 to 6 months of storage at −80°C, but could be much longer, in theory. Like OpenBiome, the NDFB uses a storing period of 2 years.
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