What is encapsulated faecal microbiota transplantation studying for patients with liver cirrhosis?

Encapsulated faecal microbiota transplantation is being studied to see if it can reduce infections and death in patients with alcohol-related or metabolic dysfunction-associated steatotic liver cirrhosis. Researchers want to understand if taking capsules containing healthy donor bacteria can improve immune function and liver health. This study is led by King's College London to address infection risks without relying on antibiotics.

Who may be eligible for this liver cirrhosis clinical trial?

Adults aged 18 years or older with confirmed alcohol-related or metabolic dysfunction-associated steatotic liver cirrhosis may be eligible. Both men and women can join if they meet other health criteria, including controlled alcohol intake and liver disease severity. People with certain allergies, recent infections, or other health conditions may be excluded. Please review eligibility criteria for more details.

Is there any cost to participate in this liver cirrhosis clinical trial?

Study-related care, including the study drug or procedure and all trial visits, is provided at no cost. Personal travel expenses may vary and are not guaranteed to be covered. Participants should plan accordingly for any travel or accommodation costs.

Actively Recruiting

Phase 3

Age: 18Years +

All Genders

ID06461208

PROMISE Trial A PROspective Randomised Double-blind Parallel Group Placebo-controlled Multicentre Trial of Faecal Microbiota Transplantation to Improve Outcomes in Patients With Cirrhosis Over 24 Months

Led by King's College London · Updated on 2026-02-24

300

Participants Needed

Research Sites

21 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are studying patients with cirrhosis caused by alcohol-related or metabolic dysfunction-associated steatotic liver disease MASLD. The trial aims to evaluate whether taking capsules containing faecal microbiota from healthy donors can reduce infections and mortality in these patients. This Phase 3 trial follows earlier research that showed faecal microbiota transplantation FMT delivered via endoscopy was safe and feasible, leading to the development of capsules for easier treatment administration. Participants will be randomly assigned to receive either encapsulated FMT or placebo capsules that look identical but contain no active treatment. They will take five capsules every three months over a total period of 21 months or until they develop an infection requiring hospital admission. This double-blind trial means neither participants nor study staff will know which treatment is given. The study will last up to 24 months including follow-up, monitoring effects on infection rates, liver health, immune system function, and antibiotic resistance. Throughout the trial, participants will be regularly assessed for infections, liver disease progression, hospital admissions, quality of life, mental health, alcohol use, and safety of FMT treatment. Laboratory tests will examine immune response and bacterial resistance. The primary outcome is the time until first infection needing hospital care. The study involves detailed monitoring and follow-up visits for up to two years to understand the treatments impact and safety in patients with cirrhosis.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Aged 18 years or older
Confirmed diagnosis of alcohol-related or metabolic dysfunction-associated steatotic liver disease (MASLD) cirrhosis
MELD score between 8 and 16
For alcohol-related cirrhosis, active alcohol consumption of 20 grams or less per day on average
Ability to provide written informed consent

You will not qualify if you...

Moderate, severe, or life-threatening food allergy (e.g., peanut allergy)
Pregnant, planning pregnancy, or breastfeeding
Recent treatment (within 14 days) for acute variceal bleeding, infection, overt hepatic encephalopathy, bacterial peritonitis, or acute on chronic liver failure (ACLF)
Active alcohol consumption greater than 20 grams per day
Previous liver transplant
Inflammatory bowel disease or coeliac disease
History of gastrointestinal surgery affecting gut microbiome (e.g., gastric bypass)
Active malignancy including hepatocellular carcinoma
Life expectancy less than 6 months or listed for liver transplantation
Infection with HIV, hepatitis B or C unless undetectable DNA/RNA
Use of antibiotics or probiotics (excluding certain foods) within 7 days prior to randomisation
Swallowing disorders or inability/unwillingness to take study medication
Participation in another investigational drug or device trial within 4 months
Any medical, psychological, familial, or social condition that may affect health, compliance, or study integrity

Research Team

Sue Cheung

Debbie Shawcross

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