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Using fecal microbiota transplantation to improve outcomes in patients with cirrhosis

PROMISE Trial: A PROspective Randomised Double-blind Parallel Group Placebo-controlled Multicentre Trial of Faecal MIcrobiota tranSplantation to Improve the Primary outcomE (First Hospitalisation Due to Infection) in Patients With Cirrhosis Over 24 Months

Phase 3 Interventional King's College London · NCT06461208

This study is testing whether a new oral capsule treatment using healthy gut bacteria can help people with cirrhosis caused by alcohol and metabolic issues feel better and reduce their risk of infections and death.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment300 (estimated)
Ages18 Years and up
SexAll
SponsorKing's College London Academic / other
Locations23 sites (Basildon and 22 other locations)
Trial IDNCT06461208 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with confirmed alcohol-related or MASLD cirrhosis and a MELD score between 8 and 16.

Not a fit: Patients with severe food allergies, active alcohol consumption, or those who have recently experienced acute liver complications may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce infection rates and mortality in patients with cirrhosis.

How similar studies have performed: Previous studies, such as the PROFIT trial, have shown that FMT is safe and feasible, indicating potential for success in this novel approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 this trial is running

Basildon and 22 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Liver CirrhosisFatty Liver AlcoholicAlcohol-related Liver DiseaseMetabolic dysfunction-Associated Steatotic Liver DiseaseMASLDMASLD-ALD overlap cirrhosisALDFaecal Microbiota Transplant
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.