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 (16) 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 MASLD-ALD Overlap cirrhosis based on clinical, radiological and/or histological criteria.

• MELD score 8-16 28

• Patients with alcohol-related cirrhosis must have been abstinent for a minimum of 4 weeks prior to randomisation.

• Patients must be deemed to have the capacity to provide written informed consent to participate.

Locations
Other Locations
United Kingdom
Royal Bournemouth Hospital
NOT_YET_RECRUITING
Bournemouth
Bristol Royal Infirmary
RECRUITING
Bristol
Southmead Hospital
RECRUITING
Bristol
Royal Derby Hospital
RECRUITING
Derby
Ninewells Hospital
RECRUITING
Dundee
Queen Elizabeth Hospital
RECRUITING
Gateshead
Queen Elizabeth University Hospital
RECRUITING
Glasgow
Hull Royal Infirmary
RECRUITING
Hull
St. James University Hospital
RECRUITING
Leeds
King's College Hospital NHS Foundation Trust
RECRUITING
London
St. George's University Hospital NHS Foundation Trust
RECRUITING
London
St. Mary's Hospital
RECRUITING
London
Freeman Hospital
RECRUITING
Newcastle Upon Tyne
Royal Gwent Hospital
RECRUITING
Newport
Queen's Medical Centre
RECRUITING
Nottingham
Derriford Hospital
RECRUITING
Plymouth
Contact Information
Primary
Sue Cheung
PROMISE@kcl.ac.uk
020 7848 0532
Backup
Debbie Shawcross
debbie.shawcross@kcl.ac.uk
020 3299 3713
Time Frame
Start Date: 2023-06-21
Estimated Completion Date: 2027-04-30
Participants
Target number of participants: 300
Treatments
Experimental: Encapsulated FMT
Placebo_comparator: Placebo
Related Therapeutic Areas
Sponsors
Collaborators: King's College Hospital NHS Trust, St George's, University of London, BRITISH LIVER TRUST, Imperial College London, Guy's and St Thomas' NHS Foundation Trust
Leads: King's College London

This content was sourced from clinicaltrials.gov

Similar Clinical Trials