Probiotic supplement versus placebo for the treatment of patients with non-alcoholic fatty liver disease: a randomized, double-blind, placebo-controlled trial
Probiotic supplement versus placebo for the treatment of patients with non-alcoholic fatty liver disease: a randomized, double-blind, placebo-controlled trial by access liver biochemistry, MRI-PDFF, fibroscan and metabolic profile
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
90
Division of gastroenterology and hepatology
Ratchathewi, Bangkok, Thailand
Chiangmai university
Chiang Mai, Thailand
Liver steatosis by fibroscan
Shear wave velocity with controlled attenuation parameter (CAP) unit in decibels per meter (dB/m)
Time frame: 12 weeks
Liver steatosis by MRI
Hepatic steatosis with MRI-PDFF (the percent ratio of the density of mobile protons from triglycerides and the total density of protons from mobile triglycerides and mobile water). Outcome Measures was report as percent
Time frame: 12 weeks
Liver stiffness by fibroscan
Fibroscan- transient elastography in kilopascals (kPa)
Time frame: 12 weeks
Liver inflammation
Evaluated alanine aminotransferase (ALT; U/L), aspartate aminotransferase (AST; U/L), gamma-glutamyl transferase (GGT; U/L), and alkaline phosphatase (ALP; U/L)
Time frame: 12 weeks
Metabolic profile
Fasting plasma glucose (FPG) in mg/dL
Time frame: 12 weeks
Metabolic profile
HbA1C in percent
Time frame: 12 weeks
Metabolic profile: HOMA IR
Fasting plasma glucose and serum insulin level will be combined to report in HOMA IR in mg/dl x mIU/L
Time frame: 12 weeks
Metabolic profile: serum lipid profiles
Total cholesterol in mg/dL, low-density lipoprotein (LDL) cholesterol in mg/dL, high-density lipoprotein (HDL) in mg/dl, cholesterol in mg/dL, and triglyceride in mg/dL
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Time frame: 12 weeks
Inflammatory marker
hsCRP level in mg/L
Time frame: 12 weeks
Inflammatory marker
Interleukin 6 (IL-6) in pg/mL
Time frame: 12 weeks
Anthropomorphic evaluation: BMI
Weight and height will be combined to report BMI in kg/m\^2
Time frame: 12 weeks
Anthropomorphic evaluation: composition analysis
Body fat in percentage
Time frame: 12 weeks
Anthropomorphic evaluation
Body muscle in kilogram
Time frame: 12 weeks