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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
SINGLE
Enrollment
20
NAFLD patients treated with Lepicol probiotic and prebiotic formula for 24 weeks.
NAFLD patients treated with lifestyle advice.
Cheng Suen Man Shook Hepatitis Center, Institute of Digestive Disease, The Chinese University of Hong Kong, Prince of Wales Hospital
Hong Kong SAR, China
The primary endpoint is the reduction in hepatic triglyceride content from baseline to week 24.
Time frame: 24 weeks
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).
Time frame: 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.
Time frame: 24 weeks
The changes in visceral fat will be determined by magnetic resonance imaging at the same session both at baseline and month 12.
Time frame: 12 months
The changes in liver fibrosis will be determined by transient elastography by Fibroscan both at baseline and month 12.
Time frame: 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.
Time frame: 12 months
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