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
Status: Recruiting
Location: See all (23) locations...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Phase 3
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. 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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
United Kingdom
Basildon University Hospital
RECRUITING
Basildon
Royal Bournemouth Hospital
RECRUITING
Bournemouth
Bristol Royal Infirmary
RECRUITING
Bristol
Southmead Hospital
RECRUITING
Bristol
Broomfield Hospital
RECRUITING
Chelmsford
Royal Derby Hospital
RECRUITING
Derby
Ninewells Hospital
RECRUITING
Dundee
Queen Elizabeth Hospital
RECRUITING
Gateshead
Glasgow Royal Infirmary
RECRUITING
Glasgow
Queen Elizabeth University Hospital
RECRUITING
Glasgow
University Hospital Hairmyres
RECRUITING
Glasgow
Hull Royal Infirmary
RECRUITING
Hull
Raigmore Hospital
RECRUITING
Inverness
St. James University Hospital
RECRUITING
Leeds
King's College Hospital NHS Foundation Trust
RECRUITING
London
St. George's University Hospital NHS Foundation Trust
Collaborators: King's College Hospital NHS Trust, BRITISH LIVER TRUST, Imperial College London, Guy's and St Thomas' NHS Foundation Trust, St George's Healthcare NHS Trust