Researchers are looking for people with cirrhosis to help test a new way of preventing infections.
116 people have already signed up to take part in the PROMISE study. Researchers are now looking for more people with cirrhosis and alcohol-related liver disease (ALD) or metabolic dysfunction-associated steatotic liver disease (MASLD or NAFLD) to take part.
People with cirrhosis can be at higher risk of dangerous infections. Doctors usually try to treat these infections with antibiotics. But the PROMISE study is looking at a very different way to deal with the problem. They are focusing on improving gut health and immune system function to prevent infections.
We all have a wide range of bacteria in our guts. They help us digest our food. But we are now learning more about the vital role they play in our immune system and in protecting us against infections. The PROMISE trial aims to find out if giving gut bacteria from healthy volunteers to people with cirrhosis can reduce their risk of getting an infection. The study is led by Professor Debbie Shawcross from King’s College London.
The PROMISE trial team celebrate the 100th person joining the study.
Promise builds on findings from the team’s first of its kind trial, the PROFIT trial. In this trial, gut bacteria was transferred to patients during an endoscopy. It showed that this was safe, with no serious side effects.
But patients told the study team that they would prefer to swallow the treatment as tablets rather than undergo an endoscopy. This is what the PROMISE trial is now doing.
In the PROMISE study, we are using faecal microbiota transplantation (FMT) capsules (or tablets). These are made from freeze-dried gut bacteria taken from stool samples donated by healthy volunteers. The bacteria are contained in a capsule that will deliver them to where they are needed.
Feedback from someone already taking part:
‘The medication has no smell or taste’
‘I felt reassured after speaking with the clinical team about the PROMISE trial’
‘I’m excited to be part of this research and the potential benefits of FMT on liver disease’
The PROMISE trial is a double-blinded placebo-controlled trial. This is the gold standard for clinical trials. It means that everyone taking part will be given either the FMT capsules or an identical placebo capsule that doesn’t have the bacteria.
You have an equal chance of being in the test or the placebo group. Neither you, or the medical team you are working with will know which group you are in.
Interested? How to take part in PROMISE
Read more about the background of the PROMISE study and what is involved if you would like to join.
We welcome any suitable patients who are interested in participating in our trial. The study is happening at 15 different centres across England and Scotland.
Please email the PROMISE trial coordinating team (PROMISE@kcl.ac.uk) and we will refer you to one of our dedicated clinical teams at your nearest PROMISE centre. They will assess and confirm your eligibility to join our study and help you through your whole participation period on the trial.
Locations
If you join the study, you will be asked to attend one of 15 hospital sites across England and Scotland every 3 months. We will be opening another 5 centres soon to offer further opportunities for our patients.
- King’s College Hospital, London
- St. George’s Hospital, London
- Queen Elizabeth Hospital, Gateshead
- St. Mary’s Hospital, London
- St. James Hospital, Leeds
- Freeman Hospital, Newcastle
- Queen’s Medical Centre, Nottingham
- Royal Derby Hospital, Derby
- Royal Bournemouth Hospital, Bournemouth
- Queen Elizabeth University Hospital, Glasgow
- Ninewells Hospital, Dundee
- Bristol Royal Infirmary, Bristol
- Derriford Hospital, Plymouth
- Southmead Hospital, Bristol
- Hull Royal Infirmary, Hull
This study started in June 2023. It is funded by the Efficacy and Mechanism Evaluation (EME) Programme, a partnership between the National Institute for Health and Care Research (NIHR) (Project Reference NIHR130730) and the Medical Research Council (MRC). Professor Debbie Shawcross from Kings College London is the Chief Investigator of the study. The trial number is ISRCTN17863382.
