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A PROspective Faecal MIcrobiota tranSplantation Trial to Improve outcomEs in Patients With Cirrhosis
Sponsor: King's College London
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.
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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
300
Start Date
2023-06-21
Completion Date
2028-06-30
Last Updated
2026-02-24
Healthy Volunteers
No
Conditions
Interventions
Encapsulated FMT
Encapsulated Faecal Microbiota Transplant
Placebo
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.
Locations (23)
Basildon University Hospital
Basildon, United Kingdom
Royal Bournemouth Hospital
Bournemouth, United Kingdom
Southmead Hospital
Bristol, United Kingdom
Bristol Royal Infirmary
Bristol, United Kingdom
Broomfield Hospital
Chelmsford, United Kingdom
Royal Derby Hospital
Derby, United Kingdom
Ninewells Hospital
Dundee, United Kingdom
Queen Elizabeth Hospital
Gateshead, United Kingdom
Glasgow Royal Infirmary
Glasgow, United Kingdom
Queen Elizabeth University Hospital
Glasgow, United Kingdom
University Hospital Hairmyres
Glasgow, United Kingdom
Hull Royal Infirmary
Hull, United Kingdom
Raigmore Hospital
Inverness, United Kingdom
St. James University Hospital
Leeds, United Kingdom
King's College Hospital NHS Foundation Trust
London, United Kingdom
St. George's University Hospital NHS Foundation Trust
London, United Kingdom
St. Mary's Hospital
London, United Kingdom
Freeman Hospital
Newcastle upon Tyne, United Kingdom
Royal Gwent Hospital
Newport, United Kingdom
Queen's Medical Centre
Nottingham, United Kingdom
Derriford Hospital
Plymouth, United Kingdom
University Hospital Southampton
Southampton, United Kingdom
Torbay Hospital
Torquay, United Kingdom