A pioneering faecal microbiota treatment implemented locally by scientists and NHS doctors at the Quadram Institute for people with recurrent infections of a superbug will benefit from a £500,000 investment in new facilities.
Faecal Microbiota Transplant (FMT) – is a National Institute for Clinical Excellence (NICE) recommended treatment for NHS patients with recurrent Clostridioides difficile (C. diff) infection.
FMT transfers the microbiota from healthy donors into patients who have recurrent C. diff infections. This is done by taking poo or poop from a healthy donor and giving it to the patient via a tube passed into their stomach. The treatment in Norwich has proved effective in more than 90 per cent of patients.
The therapy’s implementation locally at the Quadram Institute (QI) in Norwich has been led by Prof Arjan Narbad and Dr Ngozi Elumogo, consultant microbiologist at the Norfolk and Norwich University Hospital (NNUH).
Previously, 26 patients were treated at NNUH, using material prepared by QI scientists. FMT is believed to be more effective than antibiotic treatment as antibiotics can wipe out many different bacteria, not just the problematic C. diff. FMT breaks this cycle by replacing the patient’s microbiome with a healthier one, delivering almost immediate health benefits at a significantly lower cost than a course of antibiotics*.
In England there are approximately 15,000 cases of C. diff infection (CDI) a year and recent estimates put the rate of recurrence at around 15–35% of all CDI cases. Data suggests second and subsequent recurrent CDI (rCDI) is common among those patients who experience a recurrent infection. The cost to the NHS is estimated at £500 million a year.
The Biotechnology and Biological Sciences Research Council (BBSRC) has awarded a grant of £500,000 to build and equip a new facility at the Quadram Institute that meets Good Manufacturing Practice (GMP) standards. The Medicines and Healthcare products Regulatory Agency (MHRA) classes FMT as a medicine which means it needs to be produced in a GMP-standard facility.
Quadram Institute translational microbiome group leader Prof Arjan Narbad said: “This is a significant investment to create a GMP facility for Faecal Microbiota Transplant and we are grateful to BBSRC for this investment which will give us and the hospital the facilities we need to progress both a clinical service and further research into FMT.”
Work to develop the new FMT facility on the ground floor of the Quadram Institute will ensure the clinical NHS service can be extended to patients in the East of England beyond NNUH, meets MHRA standards and provides the basis for continued research into the treatment of both rCDI and other microbiome-associated health conditions, including a research clinical study funded by the charity Invest in ME Research for the application of FMT for treatment of myalgic encephalomyelitis (ME).
Prof Simon Carding said: “With the very generous support of Invest in ME Research we look forward to running our RESTORE-ME trial once the construction work and FMT facility have been completed and validated later this year.”
The construction work and validation of the FMT facility at the Quadram Institute is expected to take around nine months at which point an MHRA licence application will be submitted. Work is expected to complete in late 2022.
Consultant microbiologist Dr Ngozi Elumogo said: “Clostridioides difficile (C. diff) continues to cause significant healthcare burden, consumes resources and negatively impacts patient’s quality of life. A patient from the earlier pilot is still symptom-free six years after. Having a GMP facility will bring this superior treatment to many more of our patients.”
Invest in ME Research Chairman Kathleen McCall said: “This is excellent news that the clinical trial for ME will be able to restart following the pause caused by the pandemic, and with the vote of confidence from BBSRC in supporting the facility and trial. This is the only clinical trial for ME in the UK and one of only a few in the world and will bring forward world class research to bear on this disease and will allow us, in collaboration with Quadram Institute, to develop more research initiatives that have the potential to change the face of research into this disease.”