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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.
Ms
Sue
Cheung
promise@kcl.ac.uk
Prof
Debbie
Shawcross
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.
Infection and decompensation 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:
You can take part if:
You may not be able to take part if:
Current key exclusion criteria as of 13/02/2026:
1. Moderate, 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. Breastfeeding4. 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 or surgery that could change the gut microbiome or result in bacterial overgrowth e.g. gastric bypass10. Active malignancy including hepatocellular carcinoma11. Patients with an expected life expectancy <6 months or listed for liver transplantation12. 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 randomisation16. Patients, who in the opinion of the PI, have a medical condition, or other relevant psychological, familial, or social factor that may jeopardise their health, compliance, or influence the trial integrity in any way.
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Previous key exclusion criteria:
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.
Prof
Debbie
Shawcross
debbie.shawcross@kcl.ac.uk
Ms
Sue
Cheung
promise@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.
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
You can print or share the study information with your GP/healthcare provider or contact the research team directly.
