Portsmouth patients to be recruited in 'poo transplant' trial to test new cirrhosis liver disease treatment
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The Promise trial will investigate whether consuming freeze-dried stool can improve the gut health of patients with cirrhosis, a condition where the liver is scarred and permanently damaged. Research suggests patients with liver damage have higher levels of ‘bad’ bacteria in the gut compared with healthy individuals.
This makes them highly susceptible to infections which can be hard to treat with antibiotics, according to the scientists involved in the clinical trial. Liver disease is the third biggest cause of premature death in working age people, with about 40 deaths each day, according to the British Liver Trust, who are collaborators in the trial.
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Patients will be recruited from Portsmouth and up to 15 sites across the UK, including hospitals in London, Wales, Gateshead, Leeds, Newcastle, Nottingham, Derby, Liverpool, Glasgow, Dundee, Bristol and Plymouth. They will be randomly allocated freeze-dried stool capsules or a dummy tablet every three months for two years.
Dr Lindsey Edwards, from King’s College London, which is leading the clinical trial, said: ‘Infections, especially resistant infections, are a death sentence to liver patients.
‘Patients with chronic liver disease are often prescribed antibiotics, however, they are at high risk of multidrug-resistant infections. This is contributing to the global health crisis of antimicrobial resistance.
‘There is an urgent and unmet need to tackle infection and antimicrobial resistance in chronic liver disease. If we can boost liver patients’ own immunity to reduce infections by modifying the microbiome, we can reduce the need for the prescription of antibiotics.’
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Hide AdAbout 300 people with liver disease will be taking part in the trial funded by the National Institute for Health and Care Research UK (NIHR). They will test whether stool from healthy people, which are freeze-dried into capsules that can be ingested, reduces the likelihood of getting an infection.
A previous trial by the research team, which involved 32 people, has shown faecal microbiota transplant (FMT) to be safe and feasible. Professor Debbie Shawcross, from King’s College London, chief investigator in the trial, said the freeze-dried stools may ‘offer new hope for patients with cirrhosis who are out of treatment options’