Why is this study needed?
People die from cirrhosis young with more than 1 in 10 in their 40s. Patients with cirrhosis are very susceptible to infections, antibiotics become ineffective and patients may become infected with ‘super bugs’. There is an urgent need for antibiotic-free approaches.
Our body contains trillions of microscopic organisms called bacteria which play an important role in keeping us healthy. Many of these bacteria live within our bowel and help our immune system fight infection. There are increased numbers of ‘unfriendly’ bowel bacteria in patients with cirrhosis which emit substances which are harmful to health and disrupt the immune system.
It could be beneficial to replace the unfriendly bowel bacteria in patients with cirrhosis with bacteria donated from a healthy person by performing a type of bowel bacteria transplant (known as faecal microbiota transplantation or FMT). We have recently performed a preliminary trial of FMT, which was placed into the bowel with the help of a flexible camera (endoscopy). The study showed FMT was safe with no serious side effects, but patients told us they would prefer to take tablets rather than have an endoscopy.
What will the PROMISE TRIAL involve?
Based on patient feedback we have made a capsule which contains dried stool from a healthy donor. The patient needs to take 5 of these capsules to have the same dose as that transplanted via endoscopy in the previous trial.
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. This will be compared to a ‘dummy’ capsule that contains no FMT (placebo).
Patients will be selected at random to have FMT treatment or placebo and both the study team and the patients will not know which treatment they are taking. The patients will need to take 5 capsules every 3-months. Patients will continue treatment for a total of 21-months or until they develop their first infection leading to hospital admission and will be followed-up for a maximum of 2-years.
This study will also examine if having FMT will reduce the side effects of cirrhosis and if it has beneficial effects on the liver and immune system. We will look at whether it reduces hospital admissions, the incidence of ‘super-bug’ infections and death. Laboratory studies will look at whether FMT treatment will help the immune system fight infection.
Consultation with our patient co-applicant, patient advisory group, The British Liver Trust and Guts UK Charity have highlighted recurrent hospitalisation, over-use of antibiotics and fear of acquiring a ‘super-bug’ as being important priorities to patients.
How will we share the results?
The results and study findings will be published in conjunction with patient support groups, the wider media and the NHS. We will ensure the research impacts on the management of patients with CLD and shapes policy and guideline development.
Find out more
To find out more about the trial, and to find out how you can get involved please visit our FAQ page.
If you would be interested in participating, and think you may be eligible to participate as a stool donor, the participant information sheet is available here:
PROMISE_DONOR PIL_ v2.0_Clean_08.11.2022
If you would be interested in participating, and think you may be eligible to participate as a recipient, the participant information sheet is available here:
PROMISE_Patient PIL_ v2.0_Clean_08.11.2022
This trial is jointly funded by the National Institute for Health and Care Research (NIHR) and UK Research and Innovation (UKRI).
This website is supported by the NIHR, grant no: NIHR130370. The views expressed are those of the author(s) and not necessarily those of the NHS, NIHR or the Department of Health and Social Care.
