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

Study acronym: PROMISE
StatusRecruiting
PhasePhase 3
Started
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Record History

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  1. Primary completion date: Nov 30, 2026 to Jan 31, 2028v2 Show 6 more changesShow less
    • Primary endpoints: 1 to 2
    • Study sites: 16 to 23
    • Study completion date: Apr 30, 2027 to Jun 30, 2028
    • Secondary endpoints: 14 to 21
    • Collaborators revised (5)
    • Eligibility criteria expanded, about 1 word
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
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
(from sponsor)		 Liver Cirrhosis
Related terms Fatty Liver, Alcoholic, Fibrosis, Hepatic Encephalopathy, Hepatic Insufficiency, Infections, Liver Cirrhosis, Non-alcoholic Fatty Liver Disease
Enrollment 300 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov