PROMISE trial supporting liver disease patients launches in the South West

A trial funded by the National Institute for Health and Care Research (NIHR) and UK Research and Innovation (UKRI) is trialling the effectiveness of a new treatment for patients experiencing cirrhosis.

PROMISE (A PROspective double-blind placebo-controlled multicentre trial of faecal MIcrobiota tranSplantation to improve outcomEs in patients with cirrhosis), is recruiting 300 participants up and down the country and has recently opened at University Hospitals Plymouth NHS Trust (UHP). 

According to the British Liver Trust, who are collaborating on PROMISE, liver disease is the third biggest cause of death in working-age people with around 40 deaths occurring each day.

Patients in the advanced stages of chronic liver disease (CLD), known as cirrhosis, which is a hardening and scarring of the liver, can be very susceptible to infections. Unfortunately, some antibiotics are now becoming ineffective at treating these infections, so alternative methods need to be investigated.

Finding new treatments is important as CLD is the only major chronic disease that is on the rise in the UK. The PROMISE study, which is taking place at 16 hospitals across the UK including UHP, has been created to trial the effectiveness of a 'poo transplant' for patients experiencing cirrhosis.

Patients with cirrhosis have a higher-than-normal number of “bad” bacteria in their bowel which can disrupt their immune system, leading to increased risk of infection. It is hoped that these patients could benefit from having these bacteria replaced by bacteria from a healthy person via a poo transplant, known as a faecal microbiota transplantation (FMT).

The PROMISE trial will involve one group of patients taking a dosage of capsules containing the donor specimen every three months for two years, and another group receiving a placebo. Researchers will then measure the time it takes for patients in each group to develop an infection resulting in hospital admission and compare the results to investigate the impact FMT can have on CLD patients. The study will also investigate the impact having a poo transplant could have on cirrhosis and whether it can benefit the liver and immune system.

Talking about the trial, Professor Matthew Cramp, Consultant Hepatologist at the South West Liver Unit at UHP, said: “The South West Liver Unit is excited to be part of this study, which aims to change the gut microbiome using a type of poo transplant.

“We see many patients with liver disease who develop serious infections and this study offers hope for our patients with cirrhosis who currently have very few treatment options.”

If you are a patient at UHP who would like to know more about the PROMISE study or other research opportunities, ask your health care team.

To find out more about studies running in your area, visit: bepartofresearch.nihr.ac.uk