[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100551524":3},{"organization":4,"outcomesModule":7,"designInfo":71,"detailedDescription":84,"studyPopulation":30,"armGroups":85,"interventions":96,"overallOfficials":30,"centralContacts":104,"locations":114,"responsibleParty":431,"collaborators":433,"id":445,"slug":30,"hasResults":446,"nctId":447,"briefTitle":448,"officialTitle":449,"acronym":450,"eligibilityCriteria":451,"healthyVolunteers":446,"sex":452,"minAge":453,"maxAge":30,"enrollmentInfo":454,"targetDuration":30,"studyType":457,"phases":458,"briefSummary":460,"conditions":461,"keywords":463,"overallStatus":117,"whyStopped":30,"lastUpdateSubmitDate":481,"lastUpdatePostDateStruct":482,"startDateStruct":485,"completionDateStruct":487,"leadSponsor":489,"locationsCount":490},{"fullName":5,"class":6},"King's College London","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":17,"otherOutcomes":30},[9,13],{"measure":10,"description":11,"timeFrame":12},"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.","From date of randomisation until the date of first hospitlisation, assessed up to Month 24.",{"measure":14,"description":15,"timeFrame":16},"Defined Decompensation episode resulting in presentation to emergency department or hospital admission (time to event)","Decompensation episodes of the following:\n\n1. New onset moderate or large volume ascites requiring diuretic therapy or paracentesis\n2. Variceal Bleeding confirmed following emergency endoscopy or on CT angiography suggestive of bleeding elsewhere in the gastrointestinal tract as a consequence of portal hypertension.\n3. Overt hepatic encephalopathy (Westhaven Criteria grade 2-4)","From date of randomisation until the date of first hospitalisation, assessed up to Month 24.",[18,22,25,28,31,33,36,38,41,43,45,48,50,53,56,58,61,63,65,67,69],{"measure":19,"description":20,"timeFrame":21},"Time to first infection resulting in hospitalisation over 24 month follow up period","(former primary endpoint)","Screening - End of Visit (Month 24)",{"measure":23,"description":24,"timeFrame":21},"Incidence of decompensating events","All types of decompensating events will be included:\n\n1. hepatic encephalopathy\n2. new-onset or worsening ascites\n3. variceal bleeding",{"measure":26,"description":27,"timeFrame":21},"All-cause infection","Including infections not resulting in hospitalisation",{"measure":29,"description":30,"timeFrame":21},"Progression to ACLF (Acute on Chronic Liver Failure) i.e. the development of one or more organ failure",null,{"measure":32,"description":30,"timeFrame":21},"Incidence of antibiotic usage",{"measure":34,"description":35,"timeFrame":21},"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).",{"measure":37,"description":30,"timeFrame":21},"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\u002Fintensive care.",{"measure":39,"description":40,"timeFrame":21},"Change in liver disease severity scores","Child Pugh Score Score range: Min 5 - Max 15 (The higher score, the more worse outcome)",{"measure":39,"description":42,"timeFrame":21},"MELD Score (Model for End stage Liver Disease) Score range: Min 6 - Max 40 (The higher score, the more worse outcome)",{"measure":39,"description":44,"timeFrame":21},"UKELD Score (UK for End stage Liver Disease) Score range: Min 40 - Max 80 (The higher score, the more worse outcome)",{"measure":46,"description":47,"timeFrame":21},"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)",{"measure":49,"description":30,"timeFrame":21},"All-cause mortality and liver-related mortality.",{"measure":51,"description":52,"timeFrame":21},"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.",{"measure":54,"description":55,"timeFrame":21},"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)",{"measure":57,"description":30,"timeFrame":21},"Change in urinary ethyl glucuronide\u002Fethyl sulphate levels if tested as part of the standard of care.",{"measure":59,"description":60,"timeFrame":21},"Safety of FMT","Based on assessments including weight in kg",{"measure":59,"description":62,"timeFrame":21},"Based on safety assessments including blood pressure (mmHg)",{"measure":59,"description":64,"timeFrame":21},"Based on safety assessments including heart rate in bpm",{"measure":59,"description":66,"timeFrame":21},"Based on safety assessments, Oxygen Saturation in %",{"measure":59,"description":68,"timeFrame":21},"Based on safety assessments, measured temperatures in degrees celcius",{"measure":59,"description":70,"timeFrame":21},"Based on safety assessments including evaluation of reported adverse events or serious adverse events",{"allocation":72,"interventionModel":73,"interventionModelDescription":74,"primaryPurpose":75,"observationalModel":30,"timePerspective":30,"maskingInfo":76},"RANDOMIZED","PARALLEL","Patients will be randomised 1:1 to FMT or placebo.","PREVENTION",{"masking":77,"maskingDescription":78,"whoMasked":79},"QUADRUPLE","All participants, Chief Investigator, Site Principal Investigators and outcome assessors will be fully blinded throughout the trial. The site pharmacy trials team and the nurse administering the treatment will be unblinded to a patients treatment allocation.\n\nThe senior statistician will also be fully blinded, but the junior statistician will be unblinded from the 1st DMC meeting with data onwards.",[80,81,82,83],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR","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.\n\nPatients 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.\n\nIt 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.\n\nThe 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.\n\nThis 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.\n\nThe 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.",[86,91],{"label":87,"type":88,"description":30,"interventionNames":89},"Encapsulated FMT","EXPERIMENTAL",[90],"Drug: Encapsulated FMT",{"label":92,"type":93,"description":30,"interventionNames":94},"Placebo","PLACEBO_COMPARATOR",[95],"Other: Placebo",[97,101],{"type":98,"name":87,"description":99,"armGroupLabels":100,"otherNames":30},"DRUG","Encapsulated Faecal Microbiota Transplant",[87],{"type":6,"name":92,"description":102,"armGroupLabels":103,"otherNames":30},"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.",[92],[105,110],{"name":106,"role":107,"phone":108,"phoneExt":30,"email":109},"Sue Cheung","CONTACT","020 7848 0532","PROMISE@kcl.ac.uk",{"name":111,"role":107,"phone":112,"phoneExt":30,"email":113},"Debbie Shawcross","020 3299 3713","debbie.shawcross@kcl.ac.uk",[115,135,149,163,175,190,204,218,232,247,256,268,283,298,312,326,337,348,363,373,387,401,416],{"facility":116,"status":117,"city":118,"state":30,"zip":119,"country":120,"countryCode":121,"cosmosGeoPoint":122,"geoPoint":127,"contacts":128},"Basildon University Hospital","RECRUITING","Basildon","SS16 5NL","United Kingdom","UK",{"type":123,"coordinates":124},"Point",[125,126],0.45782,51.56844,{"lat":126,"lon":125},[129,133],{"name":130,"role":107,"phone":131,"phoneExt":30,"email":132},"Gavin Wright","0300 44 36162","gavin.wright3@nhs.net",{"name":130,"role":134,"phone":30,"phoneExt":30,"email":30},"PRINCIPAL_INVESTIGATOR",{"facility":136,"status":117,"city":137,"state":30,"zip":138,"country":120,"countryCode":121,"cosmosGeoPoint":139,"geoPoint":143,"contacts":144},"Royal Bournemouth Hospital","Bournemouth","BH7 7DW",{"type":123,"coordinates":140},[141,142],-1.8795,50.72048,{"lat":142,"lon":141},[145,148],{"name":146,"role":107,"phone":30,"phoneExt":30,"email":147},"Safa Al-Shamma","safa.al-shamma@uhd.nhs.uk",{"name":146,"role":134,"phone":30,"phoneExt":30,"email":30},{"facility":150,"status":117,"city":151,"state":30,"zip":152,"country":120,"countryCode":121,"cosmosGeoPoint":153,"geoPoint":157,"contacts":158},"Southmead Hospital","Bristol","BS10 5NB",{"type":123,"coordinates":154},[155,156],-2.59665,51.45523,{"lat":156,"lon":155},[159,162],{"name":160,"role":107,"phone":30,"phoneExt":30,"email":161},"Zeino Zeino","Zeino.Zeino@nbt.nhs.uk",{"name":160,"role":134,"phone":30,"phoneExt":30,"email":30},{"facility":164,"status":117,"city":151,"state":30,"zip":165,"country":120,"countryCode":121,"cosmosGeoPoint":166,"geoPoint":168,"contacts":169},"Bristol Royal Infirmary","BS2 8HW",{"type":123,"coordinates":167},[155,156],{"lat":156,"lon":155},[170,173],{"name":171,"role":107,"phone":30,"phoneExt":30,"email":172},"Gautham Appanna","Gautham.Appanna@uhbw.nhs.uk",{"name":174,"role":134,"phone":30,"phoneExt":30,"email":30},"Gauth Appanna",{"facility":176,"status":117,"city":177,"state":30,"zip":178,"country":120,"countryCode":121,"cosmosGeoPoint":179,"geoPoint":183,"contacts":184},"Broomfield Hospital","Chelmsford","CM1 7ET",{"type":123,"coordinates":180},[181,182],0.46958,51.73575,{"lat":182,"lon":181},[185,186,187],{"name":130,"role":107,"phone":131,"phoneExt":30,"email":132},{"name":130,"role":134,"phone":30,"phoneExt":30,"email":30},{"name":188,"role":189,"phone":30,"phoneExt":30,"email":30},"Keval Naik","SUB_INVESTIGATOR",{"facility":191,"status":117,"city":192,"state":30,"zip":193,"country":120,"countryCode":121,"cosmosGeoPoint":194,"geoPoint":198,"contacts":199},"Royal Derby Hospital","Derby","DE22 3NE",{"type":123,"coordinates":195},[196,197],-1.47663,52.92277,{"lat":197,"lon":196},[200,203],{"name":201,"role":107,"phone":30,"phoneExt":30,"email":202},"Nicholas Taylor","nicholas.taylor1@nhs.net",{"name":201,"role":134,"phone":30,"phoneExt":30,"email":30},{"facility":205,"status":117,"city":206,"state":30,"zip":207,"country":120,"countryCode":121,"cosmosGeoPoint":208,"geoPoint":212,"contacts":213},"Ninewells Hospital","Dundee","DD1 9SY",{"type":123,"coordinates":209},[210,211],-2.97489,56.46913,{"lat":211,"lon":210},[214,217],{"name":215,"role":107,"phone":30,"phoneExt":30,"email":216},"Ruairi Lynch","ruairi.lynch2@nhs.scot",{"name":215,"role":134,"phone":30,"phoneExt":30,"email":30},{"facility":219,"status":117,"city":220,"state":30,"zip":221,"country":120,"countryCode":121,"cosmosGeoPoint":222,"geoPoint":226,"contacts":227},"Queen Elizabeth Hospital","Gateshead","NE9 6SX",{"type":123,"coordinates":223},[224,225],-1.60168,54.96209,{"lat":225,"lon":224},[228,231],{"name":229,"role":107,"phone":30,"phoneExt":30,"email":230},"Dina Mansour","dina.mansour@nhs.net",{"name":229,"role":134,"phone":30,"phoneExt":30,"email":30},{"facility":233,"status":117,"city":234,"state":30,"zip":235,"country":120,"countryCode":121,"cosmosGeoPoint":236,"geoPoint":240,"contacts":241},"Glasgow Royal Infirmary","Glasgow","G4 0SF",{"type":123,"coordinates":237},[238,239],-4.25763,55.86515,{"lat":239,"lon":238},[242,246],{"name":243,"role":107,"phone":244,"phoneExt":30,"email":245},"Rachael Swann","0141 232 7600","Rachael.Swann@ggc.scot.nhs.uk",{"name":243,"role":134,"phone":30,"phoneExt":30,"email":30},{"facility":248,"status":117,"city":234,"state":30,"zip":249,"country":120,"countryCode":121,"cosmosGeoPoint":250,"geoPoint":252,"contacts":253},"Queen Elizabeth University Hospital","G51 4TF",{"type":123,"coordinates":251},[238,239],{"lat":239,"lon":238},[254,255],{"name":243,"role":107,"phone":30,"phoneExt":30,"email":245},{"name":243,"role":134,"phone":30,"phoneExt":30,"email":30},{"facility":257,"status":117,"city":234,"state":30,"zip":258,"country":120,"countryCode":121,"cosmosGeoPoint":259,"geoPoint":261,"contacts":262},"University Hospital Hairmyres","G75 8RG",{"type":123,"coordinates":260},[238,239],{"lat":239,"lon":238},[263,267],{"name":264,"role":107,"phone":265,"phoneExt":30,"email":266},"Natasha McDonald","01355 584862","natasha.mcdonald@lanarkshire.scot.nhs.uk",{"name":264,"role":134,"phone":30,"phoneExt":30,"email":30},{"facility":269,"status":117,"city":270,"state":30,"zip":271,"country":120,"countryCode":121,"cosmosGeoPoint":272,"geoPoint":276,"contacts":277},"Hull Royal Infirmary","Hull","HU3 2JZ",{"type":123,"coordinates":273},[274,275],-0.33525,53.7446,{"lat":275,"lon":274},[278,281],{"name":279,"role":107,"phone":30,"phoneExt":30,"email":280},"Lynsey Corless","lynsey.corless@nhs.net",{"name":282,"role":134,"phone":30,"phoneExt":30,"email":30},"Lynse Corless",{"facility":284,"status":117,"city":285,"state":30,"zip":286,"country":120,"countryCode":121,"cosmosGeoPoint":287,"geoPoint":291,"contacts":292},"Raigmore Hospital","Inverness","IV2 3UJ",{"type":123,"coordinates":288},[289,290],-4.22398,57.47908,{"lat":290,"lon":289},[293,297],{"name":294,"role":107,"phone":295,"phoneExt":30,"email":296},"Sebastian Wallace","01463 255952","sebastian.wallace3@nhs.scot",{"name":294,"role":134,"phone":30,"phoneExt":30,"email":30},{"facility":299,"status":117,"city":300,"state":30,"zip":301,"country":120,"countryCode":121,"cosmosGeoPoint":302,"geoPoint":306,"contacts":307},"St. James University Hospital","Leeds","LS9 7TF",{"type":123,"coordinates":303},[304,305],-1.54785,53.79648,{"lat":305,"lon":304},[308,311],{"name":309,"role":107,"phone":30,"phoneExt":30,"email":310},"Ian Rowe","I.A.C.Rowe@leeds.ac.uk",{"name":309,"role":134,"phone":30,"phoneExt":30,"email":30},{"facility":313,"status":117,"city":314,"state":30,"zip":315,"country":120,"countryCode":121,"cosmosGeoPoint":316,"geoPoint":320,"contacts":321},"King's College Hospital NHS Foundation Trust","London","SE5 9RS",{"type":123,"coordinates":317},[318,319],-0.12574,51.50853,{"lat":319,"lon":318},[322,325],{"name":323,"role":107,"phone":30,"phoneExt":30,"email":324},"Vishal Patel","vishal.patel@nhs.net",{"name":323,"role":134,"phone":30,"phoneExt":30,"email":30},{"facility":327,"status":117,"city":314,"state":30,"zip":328,"country":120,"countryCode":121,"cosmosGeoPoint":329,"geoPoint":331,"contacts":332},"St. George's University Hospital NHS Foundation Trust","SW17 0QT",{"type":123,"coordinates":330},[318,319],{"lat":319,"lon":318},[333,336],{"name":334,"role":107,"phone":30,"phoneExt":30,"email":335},"Arjuna Singayagam","asingana@sgul.ac.uk",{"name":334,"role":134,"phone":30,"phoneExt":30,"email":30},{"facility":338,"status":117,"city":314,"state":30,"zip":339,"country":120,"countryCode":121,"cosmosGeoPoint":340,"geoPoint":342,"contacts":343},"St. Mary's Hospital","W2 1NY",{"type":123,"coordinates":341},[318,319],{"lat":319,"lon":318},[344,347],{"name":345,"role":107,"phone":30,"phoneExt":30,"email":346},"Mark Thursz","m.thursz@imperial.ac.uk",{"name":345,"role":134,"phone":30,"phoneExt":30,"email":30},{"facility":349,"status":117,"city":350,"state":30,"zip":351,"country":120,"countryCode":121,"cosmosGeoPoint":352,"geoPoint":356,"contacts":357},"Freeman Hospital","Newcastle upon Tyne","NE7 7DN",{"type":123,"coordinates":353},[354,355],-1.61396,54.97328,{"lat":355,"lon":354},[358,361],{"name":359,"role":107,"phone":30,"phoneExt":30,"email":360},"Steven Masson","steven.masson@nhs.net",{"name":362,"role":134,"phone":30,"phoneExt":30,"email":30},"Steve Masson",{"facility":364,"status":365,"city":366,"state":30,"zip":367,"country":120,"countryCode":121,"cosmosGeoPoint":368,"geoPoint":372,"contacts":30},"Royal Gwent Hospital","WITHDRAWN","Newport","NP20 2UB",{"type":123,"coordinates":369},[370,371],-2.99835,51.58774,{"lat":371,"lon":370},{"facility":374,"status":117,"city":375,"state":30,"zip":376,"country":120,"countryCode":121,"cosmosGeoPoint":377,"geoPoint":381,"contacts":382},"Queen's Medical Centre","Nottingham","NG7 2UH",{"type":123,"coordinates":378},[379,380],-1.15047,52.9536,{"lat":380,"lon":379},[383,386],{"name":384,"role":107,"phone":30,"phoneExt":30,"email":385},"Guru Aithal Prasad","Guru.Aithal@nuh.nhs.uk",{"name":384,"role":134,"phone":30,"phoneExt":30,"email":30},{"facility":388,"status":117,"city":389,"state":30,"zip":390,"country":120,"countryCode":121,"cosmosGeoPoint":391,"geoPoint":395,"contacts":396},"Derriford Hospital","Plymouth","PL6 8DH",{"type":123,"coordinates":392},[393,394],-4.14305,50.37153,{"lat":394,"lon":393},[397,400],{"name":398,"role":107,"phone":30,"phoneExt":30,"email":399},"Matthew Cramp","matthew.cramp@nhs.net",{"name":398,"role":134,"phone":30,"phoneExt":30,"email":30},{"facility":402,"status":117,"city":403,"state":30,"zip":404,"country":120,"countryCode":121,"cosmosGeoPoint":405,"geoPoint":409,"contacts":410},"University Hospital Southampton","Southampton","SO16 6YD",{"type":123,"coordinates":406},[407,408],-1.40428,50.90395,{"lat":408,"lon":407},[411,415],{"name":412,"role":107,"phone":413,"phoneExt":30,"email":414},"Janisha Patel","023 8120 4149","Janisha.Patel@uhs.nhs.uk",{"name":412,"role":134,"phone":30,"phoneExt":30,"email":30},{"facility":417,"status":117,"city":418,"state":30,"zip":419,"country":120,"countryCode":121,"cosmosGeoPoint":420,"geoPoint":424,"contacts":425},"Torbay Hospital","Torquay","TQ2 7AA",{"type":123,"coordinates":421},[422,423],-3.52522,50.46198,{"lat":423,"lon":422},[426,430],{"name":427,"role":107,"phone":428,"phoneExt":30,"email":429},"James Neale","01803 656631","jamesneale@nhs.net",{"name":427,"role":134,"phone":30,"phoneExt":30,"email":30},{"type":432,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR",[434,436,438,441,443],{"name":435,"class":6},"Guy's and St Thomas' NHS Foundation Trust",{"name":437,"class":6},"Imperial College London",{"name":439,"class":440},"BRITISH LIVER TRUST","UNKNOWN",{"name":442,"class":6},"King's College Hospital NHS Trust",{"name":444,"class":6},"St George's Healthcare NHS Trust","100551524",false,"NCT06461208","A PROspective Faecal MIcrobiota tranSplantation Trial 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","PROMISE","Inclusion Criteria:\n\n1. Aged ≥ 18 years\n2. Confirmed Alcohol-related (ALD) or Metabolic dysfunction-Associated Steatotic Liver Disease (MASLD) or MetALD cirrhosis based on clinical, radiological and\u002For histological criteria.\n3. MELD score 8-16\n4. Patients with alcohol-related cirrhosis who must have an active alcohol consumption on average ≤20 grams\u002Fday \\[1 unit of alcohol contains 10mLs or 8g of alcohol\\].\n5. Patients must be deemed to have the capacity to provide written informed consent to participate.\n\nExclusion Criteria:\n\n1. Moderate, severe or life-threatening food allergy (e.g., peanut allergy)\n2. Pregnancy or planned pregnancy\\*. Urine testing will be performed at screening to rule out pregnancy in females.\n3. Breast-feeding\n4. Patients treated for acute variceal bleeding, infection, overt hepatic encephalopathy, bacterial peritonitis or ACLF within 14 days prior to randomisation.\n5. Active alcohol consumption of \\>20 grams\u002Fday \\[1 unit of alcohol contains 10mLs or 8g of alcohol\\]\n6. Had a previous liver transplant\n7. Patients with inflammatory bowel disease.\n8. Patients with coeliac disease.\n9. 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\n10. Active malignancy including hepatocellular carcinoma\n11. Patients with an expected life expectancy \\\u003C6 months or listed for liver transplantation\n12. Infected with HIV, hepatitis B or C \\[patients who have undetectable hepatitis B or C DNA\u002FRNA can be recruited\\].\n13. Patients who have received antibiotics or probiotics (excluding food stuffs containing 'live bacteria' such as live yoghurts, kefir, fermented vegetables such as sauerkraut\u002Fkombucha or cheese) within 7 days prior to randomisation.\n14. Swallowing disorder, oral-motor dyscoordination or likely inability\u002Funwillingness to ingest study medication.\n15. Patients who have received another investigational drug or device within 4 months prior to randomisation.\n16. 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.","ALL","18 Years",{"count":455,"type":456},300,"ESTIMATED","INTERVENTIONAL",[459],"PHASE3","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.",[462],"Liver Cirrhosis",[464,465,466,462,467,468,469,470,471,472,473,474,450,475,476,477,478,479,480],"Fatty Liver Alcoholic","Alcohol-related Liver Disease","Metabolic dysfunction-Associated Steatotic Liver Disease","MASLD","MASLD-ALD overlap cirrhosis","ALD","Faecal Microbiota Transplant","Metabolic Fatty Liver Disease","Fatty Liver Disease","Gut Microbiota","Cirrhosis","MetALD","Liver Decompensation","Hepatic Encephalopathy","Infection","New Onset Ascites","Variceal Bleeding","2026-02-19",{"date":483,"type":484},"2026-02-24","ACTUAL",{"date":486,"type":484},"2023-06-21",{"date":488,"type":456},"2028-06-30",{"name":5,"class":6},23]