VSL#3 on cardiovascular risk and liver injury in non-alcoholic fatty liver disease
- Conditions
- Diabetes Research Network, Oral and GastrointestinalNot Applicable
- Registration Number
- ISRCTN05474560
- Lead Sponsor
- Portsmouth Hospitals NHS Trust (UK)
- Brief Summary
2021 Results article in https://pubmed.ncbi.nlm.nih.gov/33794784/ (added 28/10/2022)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 35
1. Individuals with non-alcoholic hepatic steatosis and/or non-alcoholic steatohepatitis (either biopsy proven or based on imaging and exclusion of other causes of liver disease) at high cardiovascular risk (at least 20% risk of a cardiovascular event over the next 10 years)
2. HbA1c less than 10%
3. Age 18 to 70 years
4. Male and female participants
1. Individuals with decompensated liver cirrhosis as defined by presence of hepatic encephalopathy, ascites, variceal bleeding
2. Allergy or intolerance to VSL#3 probiotic
3. Insulin treatment
4. Chronic excess alcohol intake (>21units per week for men and >14units per week for women in the last 2 years)
5. Antibiotic treatment 4 weeks prior to the study and/or more than 3 courses of antibiotic treatment over the preceding 6 months
7. Established cardiovascular disease (ischaemic heart disease, cerebrovascular disease and peripheral vascular disease)
8. Individuals with solid organ or bone marrow transplantation
9. Steroid therapy
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Cardiovascular biomarkers pre and post intervention
- Secondary Outcome Measures
Name Time Method iver fat and inflammation - compare fibrosis risk score and structural liver changes before and after study intervention