Profermin®: Prevention of Progression in Alcoholic Liver Disease by Modulating Dysbiotic Microbiota (SYN-ALD)
Alcoholic Liver Disease, Liver Cirrhosis, Alcoholic, Probiotics
About this trial
This is an interventional prevention trial for Alcoholic Liver Disease focused on measuring Food for special medical purposes, Gut and liver axis
Eligibility Criteria
Inclusion Criteria:
Prior or ongoing harmful alcohol intake defined as an average of ≥24g alcohol/day for women and ≥36g/d for men for ≥ 5 year.
Outpatients with compensated advanced chronic alcohol-related liver disease, defined as stable patients with:
- liver stiffness ≥15 kPa and asymptomatic and/or
- New liver biopsy (<6months) with at least F3 fibrosis (kleiner) and/or
- Liver biopsy older that 6 months with liver stiffness ≥10 kPa
- Understand and speak Danish written and orally
- Informed consent
Exclusion Criteria:
- Hospitalised
- Moderete or severe Ascites, determined from imaging diagnostics
- High-risk varices needing interventional treatment (endoscopy, TIPS)
- Child-Pugh C score
- MELD-Na ≥15
- Lactose intolerance
- Coeliac disease
- Irritable bowel syndrome defined by ROME III criteria
- Antibiotic treatment the prior 3 months
- Treatment with nutritional drinks, probiotics or prebiotics within the last 3 months
- The investigator judge that the patient would not be compliant with trial medicine
- Pregnancy
- Known liver disease other than alcoholic, of any aetiology
- Severe malnutrition
- Malignancy - except spino- or basocellular skin cancer. Patients with prior malignant disease are allowed if cancer-free for at least one year
- Recent infectious gastroenteritis (for the last 6 weeks)
Sites / Locations
- FLASH - Centre of Liver Research
- Odense University Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Profermin Plus®
Fresubin®
Intervention group will be drinking the liver-specialized product Profermin Plus®, based on fermented oats, Lactobacillus Plantarum 299v, barley malt and lecithin. The product also contains Thiamin, which is beneficial in patients with liver diseases.
Fresubin® is a standard FSMP and will be used as control product. Since Profermin Plus® is a disease-specific FSMP, the documentation must prove an effect that cannot be achieved by modification of the normal diet alone or by standard FSMP's. Therefor the comparator must be a standard FSMP, i.e. a nutritionally complete FSMP with standard nutrient formulation, which may constitute the sole source of nourishment of a person, hence the reason for using Fresubin® as comparator.