Liver CirrhosisPhase 3PROMISENCT06461208
A PROspective Faecal MIcrobiota tranSplantation Trial to Improve outcomEs in Patients With Cirrhosis
A Phase 3 study testing Encapsulated FMT in people with Liver Cirrhosis, run by King's College London at 23 sites in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Cirrhosis
- What is being tested?
- Encapsulated FMT
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 23 sitesUnited Kingdom
- Study dates
- 21 Jun 2023to 30 Jun 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged ≥ 18 years
- Confirmed Alcohol-related (ALD) or Metabolic dysfunction-Associated Steatotic Liver Disease (MASLD) or MetALD cirrhosis based on clinical, radiological and/or histological criteria.
- MELD score 8-16
- 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].
- Patients must be deemed to have the capacity to provide written informed consent to participate.
Who cannot join
- Moderate, severe or life-threatening food allergy (e.g., peanut allergy)
- Pregnancy or planned pregnancy*. Urine testing will be performed at screening to rule out pregnancy in females.
- Breast-feeding
- Patients treated for acute variceal bleeding, infection, overt hepatic encephalopathy, bacterial peritonitis or ACLF within 14 days prior to randomisation.
- Active alcohol consumption of >20 grams/day [1 unit of alcohol contains 10mLs or 8g of alcohol]
- Had a previous liver transplant
Show all 16Show fewer
- Patients with inflammatory bowel disease.
- Patients with coeliac disease.
- 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
- Active malignancy including hepatocellular carcinoma
- Patients with an expected life expectancy <6 months or listed for liver transplantation
- Infected with HIV, hepatitis B or C [patients who have undetectable hepatitis B or C DNA/RNA can be recruited].
- 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.
- Swallowing disorder, oral-motor dyscoordination or likely inability/unwillingness to ingest study medication.
- Patients who have received another investigational drug or device within 4 months prior to randomisation.
- 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.
Trial locations and contacts
23 sites in 1 country. Contact the study team or a site near you to ask about taking part.
23 sites in 1 country
United Kingdom23 sites, 22 recruiting
- Recruiting
Basildon University Hospital
Basildon, SS16 5NL
Gavin Wright, 0300 44 36162, gavin.wright3@nhs.net
Gavin Wright
- Recruiting
Royal Bournemouth Hospital
Bournemouth, BH7 7DW
Safa Al-Shamma, safa.al-shamma@uhd.nhs.uk
Safa Al-Shamma
- Recruiting
Southmead Hospital
Bristol, BS10 5NB
Zeino Zeino, Zeino.Zeino@nbt.nhs.uk
Zeino Zeino
- Recruiting
Bristol Royal Infirmary
Bristol, BS2 8HW
Gautham Appanna, Gautham.Appanna@uhbw.nhs.uk
Gauth Appanna
- Recruiting
Broomfield Hospital
Chelmsford, CM1 7ET
Gavin Wright, 0300 44 36162, gavin.wright3@nhs.net
Gavin Wright
- Recruiting
Royal Derby Hospital
Derby, DE22 3NE
Nicholas Taylor, nicholas.taylor1@nhs.net
Nicholas Taylor
- Recruiting
Ninewells Hospital
Dundee, DD1 9SY
Ruairi Lynch, ruairi.lynch2@nhs.scot
Ruairi Lynch
- Recruiting
Queen Elizabeth Hospital
Gateshead, NE9 6SX
Dina Mansour, dina.mansour@nhs.net
Dina Mansour
- Recruiting
Glasgow Royal Infirmary
Glasgow, G4 0SF
Rachael Swann, 0141 232 7600, Rachael.Swann@ggc.scot.nhs.uk
Rachael Swann
- Recruiting
Queen Elizabeth University Hospital
Glasgow, G51 4TF
Rachael Swann, Rachael.Swann@ggc.scot.nhs.uk
Rachael Swann
- Recruiting
University Hospital Hairmyres
Glasgow, G75 8RG
Natasha McDonald, 01355 584862, natasha.mcdonald@lanarkshire.scot.nhs.uk
Natasha McDonald
- Recruiting
Hull Royal Infirmary
Hull, HU3 2JZ
Lynsey Corless, lynsey.corless@nhs.net
Lynse Corless
- Recruiting
Raigmore Hospital
Inverness, IV2 3UJ
Sebastian Wallace, 01463 255952, sebastian.wallace3@nhs.scot
Sebastian Wallace
- Recruiting
St. James University Hospital
Leeds, LS9 7TF
Ian Rowe, I.A.C.Rowe@leeds.ac.uk
Ian Rowe
- Recruiting
King's College Hospital NHS Foundation Trust
London, SE5 9RS
Vishal Patel, vishal.patel@nhs.net
Vishal Patel
- Recruiting
St. George's University Hospital NHS Foundation Trust
London, SW17 0QT
Arjuna Singayagam, asingana@sgul.ac.uk
Arjuna Singayagam
- Recruiting
St. Mary's Hospital
London, W2 1NY
Mark Thursz, m.thursz@imperial.ac.uk
Mark Thursz
- Recruiting
Freeman Hospital
Newcastle upon Tyne, NE7 7DN
Steven Masson, steven.masson@nhs.net
Steve Masson
- Withdrawn
Royal Gwent Hospital
Newport, NP20 2UB
- Recruiting
Queen's Medical Centre
Nottingham, NG7 2UH
Guru Aithal Prasad, Guru.Aithal@nuh.nhs.uk
Guru Aithal Prasad
- Recruiting
Derriford Hospital
Plymouth, PL6 8DH
Matthew Cramp, matthew.cramp@nhs.net
Matthew Cramp
- Recruiting
University Hospital Southampton
Southampton, SO16 6YD
Janisha Patel, 023 8120 4149, Janisha.Patel@uhs.nhs.uk
Janisha Patel
- Recruiting
Torbay Hospital
Torquay, TQ2 7AA
James Neale, 01803 656631, jamesneale@nhs.net
James Neale
About this study
Official title: 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
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.
Read the detailed description
There is an evolving crisis of chronic liver disease (CLD) in the UK and it is the only major chronic disease which is on the rise. The advanced stages of CLD, known as cirrhosis (a hardening and scarring of the liver), is the third biggest cause of death and loss of working life years behind heart disease and self-harm. People die from cirrhosis young with more than 1 in 10 in their 40s.
Patients with cirrhosis are very susceptible to infections, antibiotics become ineffective and patients may become infected with 'super bugs'. There is an urgent need for antibiotic-free approaches. The body contains trillions of microscopic organisms called bacteria which play an important role in keeping us healthy. Many of these bacteria live within our bowel and help our immune system fight infection. There are increased numbers of 'unfriendly' bowel bacteria in patients with cirrhosis which emit substances that are harmful to health and disrupt the immune system.
It could be beneficial to replace the unfriendly bowel bacteria in patients with cirrhosis with bacteria donated from a healthy person by performing a type of bowel bacteria transplant (known as faecal microbiota transplantation or FMT). The PROFIT trial was recently performed as a preliminary trial of FMT which was placed into the bowel with the help of a flexible camera (endoscopy). The study showed FMT was safe with no serious side effects, but patients told us they would prefer to take tablets rather than have an endoscopy. The chief investigator and her team have therefore made a capsule which contains dried stool from a healthy donor. Participants will need to take 5 of these capsules to achieve the same dose.
The PROMISE clinical trial is to test whether treating patients with FMT capsules will reduce the likelihood of them getting an infection by measuring the time it takes to develop an infection resulting in hospital admission. This will be compared to a 'dummy' capsule that contains no FMT (placebo). Patients will be selected at random to have FMT treatment or placebo and both the study team and the patients will not know which treatment they are taking. Participants will need to take 5 capsules every 3-months. Participants will continue treatment for a total of 21-months or until they develop their first infection leading to hospital admission and will be followed-up for a maximum of 2-years.
This study will also examine if having FMT will reduce the side effects of cirrhosis and if it has beneficial effects on the liver and immune system. The investigator team will study whether it reduces hospital admissions, the incidence of 'super-bug' infections and death. Laboratory studies will look at whether FMT treatment will help the immune system fight infection.
The World Health Organisation describes the resistance of bacteria to the effects of antibiotics as one of the biggest threats to global health. The discovery of new antibiotics has not kept pace. The government's white paper proposes a 5-year plan to tackle resistance to antibiotics. Consultation with our patient co-applicant, patient advisory group, The British Liver Trust and Guts UK Charity have highlighted recurrent hospitalisation, over-use of antibiotics and fear of acquiring a 'super-bug' as being important priorities to patients. The results and study findings will be published in conjunction with patient support groups, the wider media and the NHS. The investigator will ensure the research impacts on the management of patients with CLD and shapes policy and guideline development.
- Conditions
- Liver Cirrhosis
- Being tested
- Encapsulated FMT, Placebo
- Keywords
- Fatty Liver Alcoholic, Alcohol-related Liver Disease, Metabolic dysfunction-Associated Steatotic Liver Disease, Liver Cirrhosis, MASLD, MASLD-ALD overlap cirrhosis, ALD, Faecal Microbiota Transplant, Metabolic Fatty Liver Disease, Fatty Liver Disease, Gut Microbiota, Cirrhosis, PROMISE, MetALD, Liver Decompensation, Hepatic Encephalopathy, Infection, New Onset Ascites, Variceal Bleeding
- Medical subject headings
- Liver Cirrhosis, Fatty Liver, Alcoholic, Non-alcoholic Fatty Liver Disease, Fibrosis, Hepatic Insufficiency, Hepatic Encephalopathy, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Encapsulated FMTDrug
Encapsulated Faecal Microbiota Transplant
PlaceboOther
The placebo product contains microcrystalline methylcellulose. It is supplied as a size 0, Swedish Orange Delayed-Release capsule (DRCap) and provides a complete match with regards to the appearance (e.g., dimensions, colour) to the FMT capsules.
| Study group | Role | What they receive |
|---|---|---|
| Encapsulated FMT | Experimental | Not described Receives: Drug: Encapsulated FMT |
| Placebo | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Defined infection resulting in presentation to the emergency department or hospital admission (time to event)
To evaluate the efficacy of encapsulated FMT to reduce the susceptibility of infection in patients with cirrhosis measured by the time to first infection resulting in presentation to the emergency department or hospitalisation.
Measured: From date of randomisation until the date of first hospitlisation, assessed up to Month 24.
Defined Decompensation episode resulting in presentation to emergency department or hospital admission (time to event)
Decompensation episodes of the following:
- New onset moderate or large volume ascites requiring diuretic therapy or paracentesis
- Variceal Bleeding confirmed following emergency endoscopy or on CT angiography suggestive of bleeding elsewhere in the gastrointestinal tract as a consequence of portal hypertension.
- Overt hepatic encephalopathy (Westhaven Criteria grade 2-4)
Measured: From date of randomisation until the date of first hospitalisation, assessed up to Month 24.
Secondary outcomes (21)
Time to first infection resulting in hospitalisation over 24 month follow up period
(former primary endpoint)
Measured: Screening - End of Visit (Month 24)
Incidence of decompensating events
All types of decompensating events will be included:
- hepatic encephalopathy
- new-onset or worsening ascites
- variceal bleeding
Measured: Screening - End of Visit (Month 24)
All-cause infection
Including infections not resulting in hospitalisation
Measured: Screening - End of Visit (Month 24)
Progression to ACLF (Acute on Chronic Liver Failure) i.e. the development of one or more organ failure
Measured: Screening - End of Visit (Month 24)
Incidence of antibiotic usage
Measured: Screening - End of Visit (Month 24)
Incidence of AMR (Anti-Microbial Resistance)
(including skin and nose colonisation with methicillin-resistant Staphylococcus aureus (MRSA), vancomycin-resistant Enterococci (VRE), extended spectrum beta-lactamase producing bacteria (ESBL), fluoroquinolone-resistant gram negative and linezolid-resistant Enterococci (LRE).
Measured: Screening - End of Visit (Month 24)
Hospitalisation rates (liver-related and all-cause) (time to event) including the length of stay (time to discharge among hospitalised participants) and admission to high dependency/intensive care.
Measured: Screening - End of Visit (Month 24)
Change in liver disease severity scores
Child Pugh Score Score range: Min 5 - Max 15 (The higher score, the more worse outcome)
Measured: Screening - End of Visit (Month 24)
Change in liver disease severity scores
MELD Score (Model for End stage Liver Disease) Score range: Min 6 - Max 40 (The higher score, the more worse outcome)
Measured: Screening - End of Visit (Month 24)
Change in liver disease severity scores
UKELD Score (UK for End stage Liver Disease) Score range: Min 40 - Max 80 (The higher score, the more worse outcome)
Measured: Screening - End of Visit (Month 24)
Change in quality of life (EQ-5D-5L) scores
EQ-5D-5L Score (EuroQol-5 Dimension- 5 Levels) Score range: Min 11111 - Max 55555 (The higher score, the more worse outcome)
Measured: Screening - End of Visit (Month 24)
All-cause mortality and liver-related mortality.
Measured: Screening - End of Visit (Month 24)
Change in depression and anxiety scores (using HADS)
HADS Score (Hospital Anxiety Depression Scale) Score range: Min 0 - Max 21 (The higher score, the more worse outcome) Data for anxiety and depression to be cateogorised separately.
Measured: Screening - End of Visit (Month 24)
Change in alcohol use disorder-related events in patients enrolled with alcohol-related cirrhosis as assessed by the alcohol-use disorders identification test (AUDIT score)
AUDIT Score (Alcohol Use Disorder Identification Test) Score range: Min 0 - Max 40 (The higher score, the more worse outcome)
Measured: Screening - End of Visit (Month 24)
Change in urinary ethyl glucuronide/ethyl sulphate levels if tested as part of the standard of care.
Measured: Screening - End of Visit (Month 24)
Safety of FMT
Based on assessments including weight in kg
Measured: Screening - End of Visit (Month 24)
Safety of FMT
Based on safety assessments including blood pressure (mmHg)
Measured: Screening - End of Visit (Month 24)
Safety of FMT
Based on safety assessments including heart rate in bpm
Measured: Screening - End of Visit (Month 24)
Safety of FMT
Based on safety assessments, Oxygen Saturation in %
Measured: Screening - End of Visit (Month 24)
Safety of FMT
Based on safety assessments, measured temperatures in degrees celcius
Measured: Screening - End of Visit (Month 24)
Safety of FMT
Based on safety assessments including evaluation of reported adverse events or serious adverse events
Measured: Screening - End of Visit (Month 24)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2024
- Study start21 Jun 2023
- Primary completion31 Jan 2028 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Liver CirrhosisStudies of the same condition, open and under way.
- More trials run by King's College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be randomised 1:1 to FMT or placebo.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Collaborators
- Guy's and St Thomas' NHS Foundation Trust, Imperial College London, BRITISH LIVER TRUST, King's College Hospital NHS Trust, St George's Healthcare NHS Trust
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06461208
- Sponsor's protocol ID
- 1004822
- Other IDs
- 2022-000300-35, NIHREME130730, ISRCTN17863382
- Acronym
- PROMISE
- Status last verified
- Oct 2025
- First submitted
- 4 Jun 2024
- Last updated
- 24 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kronsten VT, Ntuli Y, Paintsil EK, Woodhouse CA, Tranah TH, Cheung S, Hagan D, Merrick B, Cape A, Maher F, Sultana K, Prossomariti D, Rodrigues S, Masterson C, Hebditch V, Zamalloa A, Mullish BH, Singanayagam A, Patel VC, Thursz MR; PROMISE study group; Goldenberg SD, Carter B, Edwards LA, Shawcross DL. PROMISE: 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-study protocol for a clinical trial. Trials. 2026 Jul 31;27(1):632. doi: 10.1186/s13063-026-09914-x.
PubMed 42947250
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06461208
- Acronym / sponsor ID
- PROMISE / 1004822
- Conditions
- Liver Cirrhosis
- Keywords
- Fatty Liver Alcoholic, Alcohol-related Liver Disease, Metabolic dysfunction-Associated Steatotic Liver Disease, Liver Cirrhosis, MASLD, MASLD-ALD overlap cirrhosis, ALD, Faecal Microbiota Transplant
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Collaborators
- Guy's and St Thomas' NHS Foundation Trust, Imperial College London, BRITISH LIVER TRUST, King's College Hospital NHS Trust, St George's Healthcare NHS Trust
- Study start
- 21 Jun 2023 (actual)
- Primary completion
- 31 Jan 2028 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 14 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
There is an evolving crisis of chronic liver disease (CLD) in the UK and it is the only major chronic disease which is on the rise. The advanced stages of CLD, known as cirrhosis (a hardening and scarring of the liver), is the third biggest cause of death and loss of working life years behind heart disease and self-harm. People die from cirrhosis young with more than 1 in 10 in their 40s.
Patients with cirrhosis are very susceptible to infections, antibiotics become ineffective and patients may become infected with 'super bugs'. There is an urgent need for antibiotic-free approaches. The body contains trillions of microscopic organisms called bacteria which play an important role in keeping us healthy. Many of these bacteria live within our bowel and help our immune system fight infection. There are increased numbers of 'unfriendly' bowel bacteria in patients with cirrhosis which emit substances that are harmful to health and disrupt the immune system.
It could be beneficial to replace the unfriendly bowel bacteria in patients with cirrhosis with bacteria donated from a healthy person by performing a type of bowel bacteria transplant (known as faecal microbiota transplantation or FMT). The PROFIT trial was recently performed as a preliminary trial of FMT which was placed into the bowel with the help of a flexible camera (endoscopy). The study showed FMT was safe with no serious side effects, but patients told us they would prefer to take tablets rather than have an endoscopy. The chief investigator and her team have therefore made a capsule which contains dried stool from a healthy donor. Participants will need to take 5 of these capsules to achieve the same dose.
The PROMISE clinical trial is to test whether treating patients with FMT capsules will reduce the likelihood of them getting an infection by measuring the time it takes to develop an infection resulting in hospital admission. This will be compared to a 'dummy' capsule that contains no FMT (placebo). Patients will be selected at random to have FMT treatment or placebo and both the study team and the patients will not know which treatment they are taking. Participants will need to take 5 capsules every 3-months. Participants will continue treatment for a total of 21-months or until they develop their first infection leading to hospital admission and will be followed-up for a maximum of 2-years.
This study will also examine if having FMT will reduce the side effects of cirrhosis and if it has beneficial effects on the liver and immune system. The investigator team will study whether it reduces hospital admissions, the incidence of 'super-bug' infections and death. Laboratory studies will look at whether FMT treatment will help the immune system fight infection.
The World Health Organisation describes the resistance of bacteria to the effects of antibiotics as one of the biggest threats to global health. The discovery of new antibiotics has not kept pace. The government's white paper proposes a 5-year plan to tackle resistance to antibiotics. Consultation with our patient co-applicant, patient advisory group, The British Liver Trust and Guts UK Charity have highlighted recurrent hospitalisation, over-use of antibiotics and fear of acquiring a 'super-bug' as being important priorities to patients. The results and study findings will be published in conjunction with patient support groups, the wider media and the NHS. The investigator will ensure the research impacts on the management of patients with CLD and shapes policy and guideline development.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Patients will be randomised 1:1 to FMT or placebo.
| Arm | Type | Receives |
|---|---|---|
| Encapsulated FMT | Experimental | Drug: Encapsulated FMT |
| Placebo | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Aged ≥ 18 years
- Confirmed Alcohol-related (ALD) or Metabolic dysfunction-Associated Steatotic Liver Disease (MASLD) or MetALD cirrhosis based on clinical, radiological and/or histological criteria.
- MELD score 8-16
- 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].
- Patients must be deemed to have the capacity to provide written informed consent to participate.
Key exclusion criteria (16 listed)
- Moderate, severe or life-threatening food allergy (e.g., peanut allergy)
- Pregnancy or planned pregnancy*. Urine testing will be performed at screening to rule out pregnancy in females.
- Breast-feeding
- Patients treated for acute variceal bleeding, infection, overt hepatic encephalopathy, bacterial peritonitis or ACLF within 14 days prior to randomisation.
- Active alcohol consumption of >20 grams/day [1 unit of alcohol contains 10mLs or 8g of alcohol]
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Encapsulated FMTEncapsulated Faecal Microbiota Transplant | Drug | Encapsulated FMT |
| PlaceboThe placebo product contains microcrystalline methylcellulose. It is supplied as a size 0, Swedish Orange Delayed-Release capsule (DRCap) and provides a complete match with regards to the appearance (e.g., dimensions, colour) to the FMT capsules. | Other | Placebo |
Primary outcome
Defined infection resulting in presentation to the emergency department or hospital admission (time to event)
Time frame: From date of randomisation until the date of first hospitlisation, assessed up to Month 24.
To evaluate the efficacy of encapsulated FMT to reduce the susceptibility of infection in patients with cirrhosis measured by the time to first infection resulting in presentation to the emergency department or hospitalisation.
Defined Decompensation episode resulting in presentation to emergency department or hospital admission (time to event)
Time frame: From date of randomisation until the date of first hospitalisation, assessed up to Month 24.
Decompensation episodes of the following: 1. New onset moderate or large volume ascites requiring diuretic therapy or paracentesis 2. Variceal Bleeding confirmed following emergency endoscopy or on CT angiography suggestive of bleeding elsewhere in the gastrointestinal tract as a consequence of portal hypertension. 3. Overt hepatic encephalopathy (Westhaven Criteria grade 2-4)
21 secondary outcomes
Time to first infection resulting in hospitalisation over 24 month follow up period
Time frame: Screening - End of Visit (Month 24)
Incidence of decompensating events
Time frame: Screening - End of Visit (Month 24)
All-cause infection
Time frame: Screening - End of Visit (Month 24)
Progression to ACLF (Acute on Chronic Liver Failure) i.e. the development of one or more organ failure
Time frame: Screening - End of Visit (Month 24)
Incidence of antibiotic usage
Time frame: Screening - End of Visit (Month 24)
Incidence of AMR (Anti-Microbial Resistance)
Time frame: Screening - End of Visit (Month 24)
Hospitalisation rates (liver-related and all-cause) (time to event) including the length of stay (time to discharge among hospitalised participants) and admission to high dependency/intensive care.
Time frame: Screening - End of Visit (Month 24)
Change in liver disease severity scores
Time frame: Screening - End of Visit (Month 24)
Change in liver disease severity scores
Time frame: Screening - End of Visit (Month 24)
Change in liver disease severity scores
Time frame: Screening - End of Visit (Month 24)
Change in quality of life (EQ-5D-5L) scores
Time frame: Screening - End of Visit (Month 24)
All-cause mortality and liver-related mortality.
Time frame: Screening - End of Visit (Month 24)
Change in depression and anxiety scores (using HADS)
Time frame: Screening - End of Visit (Month 24)
Change in alcohol use disorder-related events in patients enrolled with alcohol-related cirrhosis as assessed by the alcohol-use disorders identification test (AUDIT score)
Time frame: Screening - End of Visit (Month 24)
Change in urinary ethyl glucuronide/ethyl sulphate levels if tested as part of the standard of care.
Time frame: Screening - End of Visit (Month 24)
Safety of FMT
Time frame: Screening - End of Visit (Month 24)
Safety of FMT
Time frame: Screening - End of Visit (Month 24)
Safety of FMT
Time frame: Screening - End of Visit (Month 24)
Safety of FMT
Time frame: Screening - End of Visit (Month 24)
Safety of FMT
Time frame: Screening - End of Visit (Month 24)
Safety of FMT
Time frame: Screening - End of Visit (Month 24)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2026.
- Derived from this study: PubMed 42947250Kronsten VT, Ntuli Y, Paintsil EK, Woodhouse CA, Tranah TH, Cheung S, Hagan D, Merrick B, Cape A, Maher F, Sultana K, Prossomariti D, Rodrigues S, Masterson C, Hebditch V, Zamalloa A, Mullish BH, Singanayagam A, Patel VC, Thursz MR; PROMISE study group; Goldenberg SD, Carter B, Edwards LA, Shawcross DL. PROMISE: 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-study protocol for a clinical trial. Trials. 2026 Jul 31;27(1):632. doi: 10.1186/s13063-026-09914-x.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
23 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Encapsulated FMT in people with Liver Cirrhosis, run by King's College London at 23 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sue Cheung (020 7848 0532, PROMISE@kcl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Defined infection resulting in presentation to the emergency department or hospital admission (time to event) (time frame: From date of randomisation until the date of first hospitlisation, assessed up to Month 24.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06461208, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2026.