Actively Recruiting
A PROspective Faecal MIcrobiota tranSplantation Trial to Improve outcomEs in Patients With Cirrhosis
Led by King's College London · Updated on 2026-02-24
300
Participants Needed
23
Research Sites
262 weeks
Total Duration
On this page
Sponsors
K
King's College London
Lead Sponsor
G
Guy's and St Thomas' NHS Foundation Trust
Collaborating Sponsor
AI-Summary
What this Trial Is About
A feasibility trial called PROFIT has previously shown that FMT administered endoscopically into the jejunum in patients with cirrhosis is safe and feasible and have identified some potential mechanisms of action that warrant further interrogation. The aim of the PROMISE Trial is to evaluate the efficacy and mechanisms of action of encapsulated FMT (versus placebo) to reduce infection and mortality in patients with alcohol-related and metabolic dysfunction-Associated Steatotic Liver (MASLD) cirrhosis.
CONDITIONS
Official Title
A PROspective Faecal MIcrobiota tranSplantation Trial to Improve outcomEs in Patients With Cirrhosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 65 18 years
- Confirmed alcohol-related or metabolic dysfunction-associated steatotic liver disease (MASLD) or MetALD cirrhosis based on clinical, radiological and/or histological criteria
- MELD score between 8 and 16
- For alcohol-related cirrhosis, active alcohol consumption averaging 64 20 grams/day
- Ability to provide written informed consent
You will not qualify if you...
- Moderate, severe or life-threatening food allergy (e.g., peanut allergy)
- Pregnancy or planned pregnancy
- Breastfeeding
- Treated for acute variceal bleeding, infection, overt hepatic encephalopathy, bacterial peritonitis, or acute-on-chronic liver failure within 14 days prior to randomisation
- Active alcohol consumption greater than 20 grams/day
- Previous liver transplant
- Inflammatory bowel disease
- Coeliac disease
- History of gastrointestinal surgery affecting gut microbiome or causing bacterial overgrowth (e.g., gastric bypass)
- Active malignancy including hepatocellular carcinoma
- Expected life expectancy less than 6 months or listed for liver transplantation
- Infected with HIV, hepatitis B or C (except if undetectable DNA/RNA)
- Use of antibiotics or probiotics (excluding live food products) within 7 days prior to randomisation
- Swallowing disorders or inability/unwillingness to take study medication
- Use of another investigational drug or device within 4 months prior to randomisation
- Any medical, psychological, familial, or social condition that might affect health, compliance, or trial integrity
AI-Screening
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Trial Site Locations
Total: 23 locations
1
Basildon University Hospital
Basildon, United Kingdom, SS16 5NL
Actively Recruiting
2
Royal Bournemouth Hospital
Bournemouth, United Kingdom, BH7 7DW
Actively Recruiting
3
Southmead Hospital
Bristol, United Kingdom, BS10 5NB
Actively Recruiting
4
Bristol Royal Infirmary
Bristol, United Kingdom, BS2 8HW
Actively Recruiting
5
Broomfield Hospital
Chelmsford, United Kingdom, CM1 7ET
Actively Recruiting
6
Royal Derby Hospital
Derby, United Kingdom, DE22 3NE
Actively Recruiting
7
Ninewells Hospital
Dundee, United Kingdom, DD1 9SY
Actively Recruiting
8
Queen Elizabeth Hospital
Gateshead, United Kingdom, NE9 6SX
Actively Recruiting
9
Glasgow Royal Infirmary
Glasgow, United Kingdom, G4 0SF
Actively Recruiting
10
Queen Elizabeth University Hospital
Glasgow, United Kingdom, G51 4TF
Actively Recruiting
11
University Hospital Hairmyres
Glasgow, United Kingdom, G75 8RG
Actively Recruiting
12
Hull Royal Infirmary
Hull, United Kingdom, HU3 2JZ
Actively Recruiting
13
Raigmore Hospital
Inverness, United Kingdom, IV2 3UJ
Actively Recruiting
14
St. James University Hospital
Leeds, United Kingdom, LS9 7TF
Actively Recruiting
15
King's College Hospital NHS Foundation Trust
London, United Kingdom, SE5 9RS
Actively Recruiting
16
St. George's University Hospital NHS Foundation Trust
London, United Kingdom, SW17 0QT
Actively Recruiting
17
St. Mary's Hospital
London, United Kingdom, W2 1NY
Actively Recruiting
18
Freeman Hospital
Newcastle upon Tyne, United Kingdom, NE7 7DN
Actively Recruiting
19
Royal Gwent Hospital
Newport, United Kingdom, NP20 2UB
Withdrawn
20
Queen's Medical Centre
Nottingham, United Kingdom, NG7 2UH
Actively Recruiting
21
Derriford Hospital
Plymouth, United Kingdom, PL6 8DH
Actively Recruiting
22
University Hospital Southampton
Southampton, United Kingdom, SO16 6YD
Actively Recruiting
23
Torbay Hospital
Torquay, United Kingdom, TQ2 7AA
Actively Recruiting
Research Team
S
Sue Cheung
CONTACT
D
Debbie Shawcross
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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