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RECRUITING
NCT06461208
PHASE3

A PROspective Faecal MIcrobiota tranSplantation Trial to Improve outcomEs in Patients With Cirrhosis

Sponsor: King's College London

View on ClinicalTrials.gov

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

DRUG

Encapsulated FMT

Encapsulated Faecal Microbiota Transplant

OTHER

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