Clinical Trial

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

Study acronym: PROMISE
Recruiting Phase 3
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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2024-06-11.
Trial Details
NCT Number NCT06461208
Lead Sponsor King's College London
Collaborators: Guy's and St Thomas' NHS Foundation Trust, Imperial College London, BRITISH LIVER TRUST, King's College Hospital NHS Trust, St George's Healthcare NHS Trust
Conditions Liver Cirrhosis
Enrollment 300 participants
Start Date 2023-06-21
Primary Completion 2028-01-31 (estimated)
Study Completion 2028-06-30 (estimated)
Updated on ClinicalTrials.gov 2026-02-24