Faecal Microbiota Transplant (FMT) is a 50 ml filtered suspension of stool (0.6 g/ml) which has been prepared from a healthy human donor. FMT material is prepared from fresh stool donations (< 6 hours old) and stored at -80°C until use. The stool donation used to prepare this FMT is supplied by a donor who has been assessed to meet the donor inclusion and exclusion criteria and has tested negative for a range of microorganisms/infections.
FMT donors donate for ten days Monday to Friday over two sequential weeks. On each donation day, a batch of FMT material is prepared and stored at -80°C. Donors undergo initial clinical, social and travel risk assessment and microbiology screening for enteric and bloodborne pathogens. Enteric microbiology screening is repeated on donation day 5 and donation day 10, by testing a pooled sample of each donation produced over the previous 5 days. A further risk assessment is made on day 10 to assess any change in health from days 1-10. If on day 10 there is a change in health of the donor the donations will be discarded.
FMT involves the transfer of a faecal suspension from a healthy donor into the gastrointestinal tract of a patient with Inflammatory Bowel Disease (IBD). This has the potential to modify the gut microbiome of the patient and act as a treatment for their disease. FMT can be given either by inserting a naso-gastric tube through the nose into the stomach and using this to administer the treatment, or by directly adminstering the FMT into the colon during a colonoscopy.
FMT preparation is carried out at the University of Birmingham Microbiome Therapy Centre, within a dedicated Class 2 microbiology safety cabinet (MSC) in a containment level 2 laboratory. This is the first MHRA approved GMP licensed facility to process FMT in the UK. More information about this facility can be found on the MTC webpage MTC Webpage.