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New treatment option for Liver Cirrhosis
Official title A PROspective Faecal MIcrobiota tranSplantation Trial to Improve outcomEs in Patients With Cirrhosis
ClinicalTrials.gov ID: NCT06461208
What this study is testing
What is Encapsulated FMT?
Encapsulated FMT is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for liver cirrhosis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Aged ≥ 18 years
- Confirmed Alcohol-related (ALD) or Metabolic dysfunction-Associated Steatotic Liver Disease (MASLD) or MetALD cirrhosis based on clinical...
- 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...
- Patients must be deemed to have the capacity to provide written informed consent to participate.
You likely can't join if
- 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...
- Active alcohol consumption of \>20 grams/day [1 unit of alcohol contains 10mLs or 8g of alcohol]
- Had a previous liver transplant
See the full eligibility 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.
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Basildon, United Kingdom
- Bournemouth, United Kingdom
- Bristol, United Kingdom
- Chelmsford, United Kingdom
- Derby, United Kingdom
- Dundee, United Kingdom
- Gateshead, United Kingdom
- Glasgow, United Kingdom
- Hull, United Kingdom
- Inverness, United Kingdom
- Leeds, United Kingdom
- London, United Kingdom
- Newcastle upon Tyne, United Kingdom
- Newport, United Kingdom
- Nottingham, United Kingdom
- Plymouth, United Kingdom
- Southampton, United Kingdom
- Torquay, United Kingdom
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Basildon, United Kingdom; Bournemouth, United Kingdom; Bristol, United Kingdom; Chelmsford, United Kingdom; Derby, United Kingdom; Dundee, United Kingdom and 12 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.