Using fecal microbiota transplantation to improve outcomes in patients with cirrhosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The PROMISE Trial aims to evaluate the efficacy of encapsulated fecal microbiota transplantation (FMT) compared to a placebo in patients with cirrhosis caused by alcohol-related liver disease and metabolic dysfunction-associated steatotic liver disease (MASLD). Building on previous findings from the PROFIT trial, which demonstrated the safety of endoscopic FMT, this study seeks to explore the potential of a more patient-friendly oral capsule approach. The trial will assess the impact of FMT on reducing infections and mortality in this vulnerable patient population. By replacing harmful gut bacteria with beneficial ones from healthy donors, the study hopes to improve immune function and overall health outcomes for patients with cirrhosis.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Aged ≥ 18 years
2. Confirmed Alcohol-related (ALD) or Metabolic dysfunction-Associated Steatotic Liver Disease (MASLD) or MetALD cirrhosis based on clinical, radiological and/or histological criteria.
3. MELD score 8-16
4. Patients with alcohol-related cirrhosis who must have an active alcohol consumption on average ≤20 grams/day \[1 unit of alcohol contains 10mLs or 8g of alcohol\].
5. Patients must be deemed to have the capacity to provide written informed consent to participate.

Exclusion Criteria:

1. Moderate, severe or life-threatening food allergy (e.g., peanut allergy)
2. Pregnancy or planned pregnancy\*. Urine testing will be performed at screening to rule out pregnancy in females.
3. Breast-feeding
4. Patients treated for acute variceal bleeding, infection, overt hepatic encephalopathy, bacterial peritonitis or ACLF within 14 days prior to randomisation.
5. Active alcohol consumption of \>20 grams/day \[1 unit of alcohol contains 10mLs or 8g of alcohol\]
6. Had a previous liver transplant
7. Patients with inflammatory bowel disease.
8. 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 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 food stuffs containing 'live bacteria' such as live yoghurts, kefir, fermented vegetables such as sauerkraut/kombucha or cheese) within 7 days prior to randomisation.
14. Swallowing disorder, oral-motor dyscoordination or likely inability/unwillingness to ingest study medication.
15. Patients who have received another investigational drug or device within 4 months prior to randomisation.
16. 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.

Where it's running

• Basildon University Hospital
  Basildon, United Kingdom Recruiting
• Royal Bournemouth Hospital
  Bournemouth, United Kingdom Recruiting
• Southmead Hospital
  Bristol, United Kingdom Recruiting
• Bristol Royal Infirmary
  Bristol, United Kingdom Recruiting
• Broomfield Hospital
  Chelmsford, United Kingdom Recruiting
• Royal Derby Hospital
  Derby, United Kingdom Recruiting

Study contacts

• Study coordinator: Sue Cheung
• Email: PROMISE@kcl.ac.uk
• Phone: 020 7848 0532

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.