Status:
ACTIVE_NOT_RECRUITING
Profermin®: Prevention of Progression in Alcoholic Liver Disease by Modulating Dysbiotic Microbiota
Lead Sponsor:
Odense University Hospital
Collaborating Sponsors:
Region of Southern Denmark
Odense Patient Data Explorative Network
Conditions:
Alcoholic Liver Disease
Liver Cirrhosis, Alcoholic
Eligibility:
All Genders
30-75 years
Phase:
NA
Brief Summary
Investigators wishes to influence the gut microbiota in patients with alcoholic liver disease in a randomized controlled clinical trial. The investigators hypothesize that the alcohol-related dysbiosi...
Detailed Description
Chronic alcohol overuse is associated with increased gut permeability and in addition, the intestinal microbiota changes qualitatively (dysbiosis) and quantitatively (bacterial overgrowth) in alcoholi...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
March 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2031
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT03863730
Start Date
March 1 2019
End Date
February 1 2031
Last Update
November 7 2023
Active Locations (2)
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1
FLASH - Centre of Liver Research
Odense, Fyn, Denmark, 5000
2
Odense University Hospital
Odense, Denmark, 5000