A PROspective Faecal MIcrobiota tranSplantation Trial to Improve outcomEs in Patients With Cirrhosis (NCT06461208) | Clinical Trial Compass
RecruitingPhase 3
A PROspective Faecal MIcrobiota tranSplantation Trial to Improve outcomEs in Patients With Cirrhosis
United Kingdom300 participantsStarted 2023-06-21
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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 \[1 unit of alcohol contains 10mLs or 8g of alcohol\].
✓. Patients must be deemed to have the capacity to provide written informed consent to participate.
Exclusion criteria
✕. 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.
✕. Active alcohol consumption of \>20 grams/day \[1 unit of alcohol contains 10mLs or 8g of alcohol\]
✕. Had a previous liver transplant
✕. Patients with inflammatory bowel disease.
✕
What they're measuring
1
Defined infection resulting in presentation to the emergency department or hospital admission (time to event)
Timeframe: From date of randomisation until the date of first hospitlisation, assessed up to Month 24.
2
Defined Decompensation episode resulting in presentation to emergency department or hospital admission (time to event)
Timeframe: From date of randomisation until the date of first hospitalisation, assessed up to Month 24.