Nonalcoholic Fatty Liver Disease
Conditions
Brief summary
The investigators' aim is to determine whether probiotic and prebiotic treatment plus lifestyle advice is more effective in reducing hepatic fat content than lifestyle advice alone in patients with Nonalcoholic Fatty Liver Disease (NAFLD).
Interventions
DRUGLepicol probiotic & prebiotic formula
NAFLD patients treated with Lepicol probiotic and prebiotic formula for 24 weeks.
NAFLD patients treated with lifestyle advice.
Sponsors
Chinese University of Hong Kong
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Age 18 to 70 years * Fatty liver identified by imaging studies including ultrasound, computer tomography or magnetic resonance imaging * Elevated alanine aminotransferase (ALT) according to Prati's criteria (\>30 IU/l in men and \>19 IU/l in women)18 * Written informed consent obtained
Exclusion criteria
* Positive hepatitis B surface antigen, anti-hepatitis C virus antibody, or anti-nuclear antibody titer above 1/160 * Alcohol consumption above 30 g per week in men or 20 g per week in women * ALT above 10 times the upper limit of normal * Liver decompensation, as evidenced by bilirubin above 50 µmol/l, platelet count below 100 × 109/l, prothrombin time above 1.3 times the upper limit of normal, albumin below 35 g/l, presence of ascites or varices * Use of systemic corticosteroids and methotrexate in the last 6 months * Evidence of hepatocellular carcinoma * Terminal illness or cancer, unless in complete remission for more than 5 years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is the reduction in hepatic triglyceride content from baseline to week 24. | 24 weeks |
Secondary
| Measure | Time frame |
|---|---|
| The proportion of patients with normal ALT at week 24 will be determined. Normal ALT is defined according to Prati's cutoffs (≤30 IU/l in men and ≤19 IU/l in women). | 24 weeks |
| The proportion of patients with impaired fasting glucose, diabetes, insulin resistance (estimated by the homeostasis model), hypertension, dyslipidemia and metabolic syndrome will be determined both at baseline and during each visit. | 24 weeks |
| The changes in visceral fat will be determined by magnetic resonance imaging at the same session both at baseline and month 12. | 12 months |
| The changes in liver fibrosis will be determined by transient elastography by Fibroscan both at baseline and month 12. | 12 months |
| The percentage of total sequences of individual microbes will be calculated. In particular, the proportion of Firmicutes and Bacteroidetes will be compared between the two treatment arms. | 12 months |
Countries
China
Outcome results
None listed