Diabetes Research Network, Oral and Gastrointestinal Not Applicable
Conditions
Interventions
Two study visits per participant, randomised to receive either treatment or placebo on a 1:1 ratio. Treatment arm will take VSL#3 probiotic 2 sachets twice a day for 10 weeks. Placebo arm will take pl
Sponsors
Portsmouth Hospitals NHS Trust (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cardiovascular biomarkers pre and post intervention | — |
Secondary
| Measure | Time frame |
|---|---|
| Liver fat and inflammation - compare fibrosis risk score and structural liver changes before and after study intervention | — |
Countries
England, United Kingdom
Outcome results
None listed