RecruitingPHASE3INTERVENTIONAL

A PROspective Faecal MIcrobiota tranSplantation Trial to Improve outcomEs in Patients With Cirrhosis

The PROMISE trial is looking for people with liver scarring (cirrhosis) caused by alcohol or fatty liver disease. This condition can lead to frequent, serious infections. Researchers are testing a new capsule treatment called Faecal Microbiota Transplantation (FMT), which contains healthy gut bacteria from donors. The idea is to replace 'unfriendly' bacteria in the gut of people with cirrhosis, which disrupt their immune system and make them prone to infections. This trial hopes to find out if these FMT capsules can reduce the number of infections that lead to hospital stays. Half the participants will get the FMT capsules, and the other half will get 'dummy' capsules (placebo). This is a Phase 3 study, meaning it’s a big step towards potentially making this treatment widely available if it proves safe and effective.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

King's College London

Enrolment target

300

Start

21 Jun 2023

Estimated completion

30 Jun 2028

Liver Cirrhosis

What is this study about?

Many people in the UK are living with ongoing liver problems. One of the more serious stages of liver disease is called cirrhosis, which is when the liver becomes scarred and hardened. Sadly, cirrhosis is a major cause of early death in the UK, often affecting people in their 40s.

People with cirrhosis are especially vulnerable to infections, and sometimes antibiotics don't work as well. Our bodies are full of tiny living things, especially in our gut, called bacteria. These bacteria are very important for keeping us healthy and helping our immune system fight off infections. However, in people with cirrhosis, the balance of these gut bacteria can shift, with more 'unfriendly' ones appearing. These unfriendly bacteria can release harmful substances and weaken the immune system, making infections more likely.

The PROMISE trial is testing a new way to help by replacing these unfriendly gut bacteria with healthy ones from a donor. This is done using a treatment called Faecal Microbiota Transplantation (FMT). In the past, this was done using a tube, but previous studies showed people would prefer to take tablets. So, for the PROMISE trial, researchers have developed special capsules containing dried stool from healthy donors. Participants will take five of these capsules to get the right dose. This study aims to see if taking these capsules can reduce severe infections and improve health for people with cirrhosis.

Key takeaways

Tests a new capsule treatment (FMT) for liver scarring (cirrhosis).
Focuses on preventing serious infections in patients.
Compares FMT capsules to 'dummy' capsules (placebo).
Suitable for adults with alcohol-related or MASLD cirrhosis.
Aims to improve gut bacteria balance.
Participation includes taking capsules and regular health monitoring.

Who may be eligible?

This study is looking for adults aged 18 or over who have liver scarring (cirrhosis) caused by alcohol or a condition called Metabolic dysfunction-Associated Steatotic Liver Disease (MASLD).

There are some specific requirements. If your cirrhosis is alcohol-related, you should typically drink no more than 20 grams of alcohol per day (which is about 2.5 units). You also need to be well enough to understand and agree to take part in the study. Your doctor will assess your liver health using a score called MELD, and it needs to be between 8 and 16.

However, you won't be able to join if you are pregnant, breastfeeding, or have certain allergies like a severe peanut allergy. Other reasons you might not be able to participate include having certain active infections, significant gut problems like inflammatory bowel disease, or if you've recently had a liver transplant. You also can't be taking antibiotics or probiotics (other than those found in foods like live yoghurts) within 7 days of starting the study, or if you have a swallowing problem that would make taking capsules difficult.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have liver cirrhosis caused by alcohol or MASLD?
Do you have a MELD score between 8 and 16 (your doctor can tell you this)?
Are you able to provide written consent to take part in a study?
Are you currently pregnant or breastfeeding?
Have you been diagnosed with inflammatory bowel disease or coeliac disease?

Answer every question to see your result.

What does participation involve?

If you join the PROMISE trial, you'll be given either the FMT capsules or 'dummy' capsules (placebo), and neither you nor your doctor will know which you are taking. You will need to take 5 capsules as your main treatment. The researchers will then carefully monitor your health to see if the capsules help reduce infections that require hospital visits. The study will involve regular check-ups and assessments, but the exact number of visits and the total duration aren't fully detailed in this summary. It's important to discuss the full schedule with the study team.

Potential risks and benefits

Taking part in this study could potentially reduce your risk of serious infections and improve your overall health if the FMT capsules prove effective. However, as with any new treatment, there might be unknown risks or side effects, even though a previous study suggested that FMT was safe. You might also find that the capsules don't help your condition. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (23)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Basildon University Hospital
Verified postcode
Basildon, United Kingdom· Recruiting
Royal Bournemouth Hospital
Verified postcode
Bournemouth, United Kingdom· Recruiting
Southmead Hospital
Verified postcode
Bristol, United Kingdom· Recruiting
Bristol Royal Infirmary
Verified postcode
Bristol, United Kingdom· Recruiting
Broomfield Hospital
Verified postcode
Chelmsford, United Kingdom· Recruiting
Royal Derby Hospital
Verified postcode
Derby, United Kingdom· Recruiting
Ninewells Hospital
Verified postcode
Dundee, United Kingdom· Recruiting
Queen Elizabeth Hospital
Verified postcode
Gateshead, United Kingdom· Recruiting
Glasgow Royal Infirmary
Verified postcode
Glasgow, United Kingdom· Recruiting
Queen Elizabeth University Hospital
Verified postcode
Glasgow, United Kingdom· Recruiting
University Hospital Hairmyres
Verified postcode
Glasgow, United Kingdom· Recruiting
Hull Royal Infirmary
Verified postcode
Hull, United Kingdom· Recruiting

Common questions

What is cirrhosis and why is it a problem?

Cirrhosis is severe scarring of the liver. It's serious because it stops your liver from working properly and can make you very prone to infections.

What is 'Faecal Microbiota Transplantation' (FMT)?

FMT is a treatment where healthy gut bacteria from a donor are given to a patient to help rebalance their gut, in this case, using capsules.

Why are you using capsules instead of the previous method?

A previous study showed capsules would be much preferred by patients over a procedure using a flexible camera (endoscopy).

What does 'placebo' mean in this trial?

A placebo is a 'dummy' capsule that doesn't contain the active treatment. It helps researchers compare the real treatment's effects.

Will I know if I'm getting the real capsules or the placebo?

No, neither you nor your doctor will know which capsules you are receiving. This is a standard way to get accurate results in trials.

How to find out more

Sue Cheung

PROMISE@kcl.ac.uk 020 7848 0532 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.