Treatment of Nonalcoholic Fatty Liver Disease With Probiotics and Prebiotics

Study Overview
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Brief Summary
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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).

Conditions
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Nonalcoholic Fatty Liver Disease

Intervention / Treatment
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* Drug: Lepicol probiotic & prebiotic formula
* Other: Simple lifestyle advice


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Lepicol probiotic & prebiotic formula+simple lifestyle advice<br> | Drug: Lepicol probiotic & prebiotic formula<br>* NAFLD patients treated with Lepicol probiotic and prebiotic formula for 24 weeks.<br>Other: Simple lifestyle advice<br>* NAFLD patients treated with lifestyle advice.<br>|
| Placebo Comparator: Simple lifestyle advice alone<br> | Other: Simple lifestyle advice<br>* NAFLD patients treated with lifestyle advice.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary endpoint is the reduction in hepatic triglyceride content from baseline to week 24. |  | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 |