Published: 22 June 2023
Researchers will test the effectiveness of a ‘faecal transplant’ for people with advanced liver disease, in a new clinical trial.
The PROMISE trial is funded by an NIHR and Medical Research Council (MRC) partnership and led by experts at King’s College London.
Researchers aim to recruit UK patients with end-stage chronic liver disease, also known as cirrhosis (irreversible scarring of the liver). They will test whether taking oral capsules made from freeze-dried stool from healthy volunteers reduces the likelihood of patients with cirrhosis getting an infection. The technique is called Faecal Microbiota Transplant (FMT).
Cirrhosis is the third biggest cause of death and loss of working life in the UK. The human body contains trillions of bacteria. But people with the condition have an increased number of ‘bad’ bacteria in their bowels. This makes them more vulnerable to infections - which in some cases can be fatal. Over-prescribing antibiotics means the drugs are becoming less effective to treat these infections, and can lead to ‘super-bugs’.
In many cases, the only definitive treatment option for cirrhosis patients is a liver transplant. However this cannot be safely performed if the patient has an antimicrobial resistant infection.
NIHR previously funded the researchers’ pilot trial called PROFIT. That study involved 32 patients. Researchers replaced bad bowel bacteria in patients’ gut with healthy bacteria by FMT via an endoscopy. The findings show the treatment was safe and well-tolerated in these patients and improves gut health. They were published at today’s EASL 2023 Congress in Vienna, Austria.
Chief Investigator Professor Debbie Shawcross from King’s College London, said: “This landmark trial provides evidence that a faecal transplant can improve gut health by modifying the gut microbiome and reduce ammonia levels in patients with cirrhosis. Initial findings from PROFIT are promising news for patients with chronic liver disease who are in desperate need of alternative treatment options.”
PROMISE will build on these findings by recruiting 300 patients from 16 UK sites. Researchers will deliver FMT via oral capsules, making the procedure less invasive for patients.
Participants will be allocated randomly to receive either FMT capsules or a placebo every 3 months for 2 years.
Dr Lindsey Edwards, from King’s College London, said: “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. This will reduce the incidence of antimicrobial resistance which is a huge global challenge.”
NIHR’s Research for Patient Benefit (RfPB) programme funded the PROFIT trial.
The PROMISE trial is funded by the Efficacy and Mechanism Evaluation (EME) Programme - an NIHR and MRC partnership.
NIHR's Clinical Research Network (CRN) will support the recruitment of participants in England and Wales.