A PROspective Faecal MIcrobiota tranSplantation Trial to Improve outcomEs in Patients With Cirrhosis
ConditionLiver Cirrhosis
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorKing's College London
About this trial
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 criteria
Qualifiers
Aged ≥ 18 years
Confirmed Alcohol-related (ALD) or Metabolic dysfunction-Associated Steatotic Liver Disease (MASLD) or MetALD cirrhosis based on clinical, radiological and/or histological criteria.
MELD score 8-16
Patients with alcohol-related cirrhosis who must have an active alcohol consumption on average ≤20 grams/day [1 unit of alcohol contains 10mLs or 8g of alcohol].
Disqualifiers
Moderate, severe or life-threatening food allergy (e.g., peanut allergy)
Pregnancy or planned pregnancy*. Urine testing will be performed at screening to rule out pregnancy in females.
Breast-feeding
Patients treated for acute variceal bleeding, infection, overt hepatic encephalopathy, bacterial peritonitis or ACLF within 14 days prior to randomisation.
Trial design
Treatments tested in this trial
- Encapsulated FMT
- Placebo
Treatment groups
300 Participants
are divided into 2 treatment groupsSponsors and collaborators
King's College London
Lead sponsor
Guy's and St Thomas' NHS Foundation Trust
Collaborator
Imperial College London
Collaborator
BRITISH LIVER TRUST
Collaborator
King's College Hospital NHS Trust
Collaborator
St George's Healthcare NHS Trust
Collaborator
Source ClinicalTrials.gov