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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.

Contact Information:

Ms Sue Cheung
+44 (0)20 7848 0532
promise@kcl.ac.uk


Prof Debbie Shawcross
+44 (0)203 299 3713
debbie.shawcross@kcl.ac.uk


More information about this study, what is involved and how to take part can be found on the study website.

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Be Part of Research - Trial Details - A clinical trial to test whether treating patients with liver cirrhosis with capsules containing healthy stool bacteria or a dummy capsule (placebo) will reduce the time it takes to develop an infection resulting in hospital admission
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A clinical trial to test whether treating patients with liver cirrhosis with capsules containing healthy stool bacteria or a dummy capsule (placebo) will reduce the time it takes to develop an infection resulting in hospital admission

Recruiting

Open to: All Genders

Age: Adult

Newcastle upon Tyne Dundee Newport Derby Glasgow London Nottingham Bournemouth London London Leeds Gateshead

Medical Conditions

Infection in patients with cirrhosis

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


Our body contains trillions of bacteria. Many of these live in our bowels 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) could be highly beneficial and reduce antibiotic usage. Findings from the initial FMT trial (the PROFIT trial) showed that FMT administered during endoscopy was safe with no serious side effects. However, patients said that they would prefer to take tablets rather than have an endoscopy. The researchers have therefore made an FMT capsule from freeze-dried stool and this study will test whether treating patients with these FMT capsules reduces their likelihood of getting an infection.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

21 Jun 2023 30 Jan 2026

Participants will be selected at random to take FMT capsules or 'dummy’ capsules that contain no FMT (placebo) and both the study team and the participants will not know which treatment they are taking. The participants will need to take five capsules every 3 months 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 whether FMT reduces the side effects of cirrhosis and has beneficial effects on the liver and immune system. The researchers will look at whether FMT 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.


Patients aged 18 years and above who have been 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

You can take part if:



You may not be able to take part if:


1. Severe or life-threatening food allergy (e.g., peanut allergy)2. Pregnancy or planned pregnancy. Urine testing will be performed at randomisation to rule out pregnancy in females3. Breastfeeding 4. Patients treated for acute variceal bleeding, infection, overt hepatic encephalopathy, bacterial peritonitis or ACLF within 14 days prior to randomisation5. Active alcohol consumption of >20 g/day (1 unit of alcohol contains 10 ml or 8 g of alcohol)6. Had a previous liver transplant7. Patients with inflammatory bowel disease8. Patients with coeliac disease.9. Patients with a history of prior gastrointestinal resection such as gastric bypass 10. Active malignancy including hepatocellular carcinoma 11. Patients with an expected life expectancy <6 months or listed for liver transplantation 12. Infected with HIV, hepatitis B or C (patients who have undetectable hepatitis B or C DNA/RNA can be recruited)13. Patients who have received antibiotics or probiotics (excluding foodstuffs containing ‘live bacteria’ such as live yoghurts, kefir, fermented vegetables such as sauerkraut/kombucha or cheese) within 7 days prior to randomisation14. Swallowing disorder, oral-motor dyscoordination or likely inability/unwillingness to ingest study medication15. Patients who have received another investigational drug or device within 4 months prior to randomisation


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Freeman Road Hospital
    Freeman Road High Heaton
    Newcastle upon Tyne
    NE7 7DN
  • Ninewells Hospital
    Ninewells Avenue
    Dundee
    DD1 9SY
  • Royal Gwent Hospital
    Cardiff Road
    Newport
    NP20 2UB
  • Royal Derby Hospital
    Uttoxeter Road
    Derby
    DE22 3NE
  • Glasgow Royal Infirmary
    84 Castle Street
    Glasgow
    G4 0SF
  • St Georges Hospital
    Blackshaw Road
    London
    SW17 0QT
  • Queens Medical Centre
    Nottingham University Hospital Derby Road
    Nottingham
    NG7 2UH
  • Royal Bournemouth Hospital
    Castle Lane East
    Bournemouth
    BH7 7DW
  • King's College Hospital
    Institute of Liver Studies Denmark Hill
    London
    SE5 9RS
  • Imperial College Healthcare NHS Foundation Trust
    Department Faculty of Medicine Department of Metabolism, Digestion and Reproduction Norfolk Place St Mary’s Campus
    London
    W2 1PG
  • St James University Hospital
    Leeds Institute for Data Analytics Room 6.1, Level 6 Clinical Sciences Building University of Leeds Beckett Street
    Leeds
    LS9 7TF
  • Queen Elizabeth Hospital
    Sherriff Hill
    Gateshead
    NE9 6SX

Patients will be taking part in a new and innovative trial to assess the beneficial effects of FMT capsules in patients with cirrhosis. There are no curative treatments available to patients with cirrhosis, aside from liver transplantation. Unfortunately, due to the scarcity of donor organs, even those listed for transplant can wait months or even years for a new liver. Others are too unwell or frail or deemed ineligible to be listed for a liver transplant.
The researchers will also gather information during the trial on how the FMT works in patients with cirrhosis including the impact on the make-up and function of the gut microbiome. They will examine whether FMT can reduce the likelihood of developing an infection and being admitted to the hospital.
There are no risks involved in taking part with regard to the samples being obtained, and the amount of blood taken will not be harmful to the patient. The placebo treatment is not harmful but is not expected to have any benefit as it contains no active drug or treatment. All patients, regardless of whether they receive placebo or FMT have the same rigorous follow-up and support from the trials team. They will be closely monitored after the treatment is given and will be seen at regular intervals afterwards to see if they have experienced any side effects. The researchers do not anticipate any serious problems to occur after the FMT or placebo treatment, but the participants will be given contact numbers should they run into any problems outside of the trial visits.

Ms Sue Cheung
+44 (0)20 7848 0532
promise@kcl.ac.uk


Prof Debbie Shawcross
+44 (0)203 299 3713
debbie.shawcross@kcl.ac.uk



More information about this study, what is involved and how to take part can be found on the study website.


The study is sponsored by King's College Hospital NHS Foundation Trust and funded by Efficacy and Mechanism Evaluation Programme.



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Read full details for Trial ID: ISRCTN17863382

Or CPMS 56066

Last updated 22 November 2024

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