A PROspective Faecal MIcrobiota tranSplantation Trial to Improve outcomEs in Patients With Cirrhosis
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
King's College London
300 participants
Jun 21, 2023
INTERVENTIONAL
Conditions
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
Inclusion Criteria5
- 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 Criteria16
- 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.
- Patients with coeliac disease.
- Patients with a history of prior gastrointestinal resection or surgery that could change the gut microbiome or result in bacterial overgrowth e.g. gastric bypass
- Active malignancy including hepatocellular carcinoma
- Patients with an expected life expectancy \<6 months or listed for liver transplantation
- Infected with HIV, hepatitis B or C \[patients who have undetectable hepatitis B or C DNA/RNA can be recruited\].
- Patients who have received antibiotics or probiotics (excluding food stuffs containing 'live bacteria' such as live yoghurts, kefir, fermented vegetables such as sauerkraut/kombucha or cheese) within 7 days prior to randomisation.
- Swallowing disorder, oral-motor dyscoordination or likely inability/unwillingness to ingest study medication.
- Patients who have received another investigational drug or device within 4 months prior to randomisation.
- Patients, who in the opinion of the PI, have a medical condition, or other relevant psychological, familial, or social factor that may jeopardise their health, compliance, or influence the trial integrity in any way.
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Interventions
Encapsulated Faecal Microbiota Transplant
The placebo product contains microcrystalline methylcellulose. It is supplied as a size 0, Swedish Orange Delayed-Release capsule (DRCap) and provides a complete match with regards to the appearance (e.g., dimensions, colour) to the FMT capsules.
Locations(23)
View Full Details on ClinicalTrials.gov
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NCT06461208