A PROspective faecal MIcrobiota tranSplantation trial to improve outcomEs in patients with cirrhosis
Research type
Research Study
Full title
A PROspective randomised double-blind parallel-group placebo-controlled multicentre trial of faecal MIcrobiota tranSplantation to improve the primary outcomE (first hopsitalisation due to infection) in patients with cirrhosis over 24 months.
IRAS ID
1004822
Contact name
Professor Debbie Shawcross
Contact email
Sponsor organisation
King's College London
Eudract number
2022-000300-35
ISRCTN Number
ISRCTN17863382
Research summary
Background: Our body contains trillions of bacteria. Many of these live in our bowel which keeps us healthy and helps our immune system to fight against infections. However, an increased number of ‘unfriendly’ bacteria are found in the bowel of patients with liver cirrhosis (permanent liver damage), which makes them highly susceptible to infections. Antibiotics are becoming less effective as they are used so frequently, and the bowel can become infected with ‘super-bugs’. Replacing the unfriendly bowel bacteria in patients with cirrhosis with healthy bacteria donated from healthy volunteers (Faecal Microbiota Transplantation [FMT]) could be highly beneficial and reduce antibiotic usage. Findings from our initial FMT trial (PROFIT Trial) showed that FMT administered during endoscopy was safe with no serious side effects. However, patients told us that they would prefer to take tablets rather than have an endoscopy.
Design: We will perform a clinical trial to test whether treating patients with FMT capsules will reduce the likelihood of them getting an infection by measuring the time it takes to develop an infection resulting in hospital admission. Patients will be randomly allocated to receive the FMT or placebo. They will need to take 5 capsules every 3-months and will be followed up for 2 years until they develop an infection.
Disease Area: Liver Cirrhosis (Alcohol-related and metabolic associated fatty liver disease cirrhosis)
Eligibility: Patients diagnosed with alcohol-related cirrhosis or non-alcoholic fatty liver disease (sometimes referred to as metabolic-associated fatty liver disease) cirrhosis at any time point and are aged 18 years and above, will be eligible to take part in this study.
Sites: We plan to recruit from up to 16 UK centres serving populations where rates of alcohol and metabolic-associated (MAFLD) liver disease are amongst the highest in the UK. This encompasses North East and North West England, the Midlands, London, Wales and Scotland.REC name
East of England - Cambridge South Research Ethics Committee
REC reference
22/EE/0247
Date of REC Opinion
16 Mar 2023
REC opinion
Further Information Favourable Opinion