A study for evaluating the improvement effect of non-alcoholic steatohepatitis (NASH) of probiotics
Non-alcoholic fatty liver disease progresses to fatty liver, hepatitis, cirrhosis, and liver cancer, resulting in a high mortality rate. The prevalence of non-alcoholic fatty liver disease at home and abroad is a major social and economic burden. However, there is no cure for non-alcoholic fatty liver disease. Recently, intestinal axis theory related to the development of chronic liver disease and microbial community has emerged. Intake of probiotics is known to play a role in regulating gut microflora. Improvement of non-alcoholic fatty liver disease can be expected through administration of probiotics.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SCREENING
Masking
SINGLE
Enrollment
120
* Experimental group Main ingredients: P. pentosaceus KID7, L. lactis CKDB001 or L. helveticus CKDB001 (containing 9 × 10\^9 CFU / day) * Control group Main ingredient: Crystalline cellulose
Hallym University Chuncheon Sacred Heart Hospital
Chuncheon, Gangwon-do, South Korea
RECRUITINGDemographic characteristics
The gender, date of birth, age, menstruation, and amenorrhea, FAMILY HISTORY
Time frame: 1 week
Primary Outcomes; Liver Function Test
Primary outcomes of liver function enzyme level (AST, ALT, rGT, CHOL, ALP)\[IU/L\]
Time frame: Baseline of AST, ALT, rGT, CHOL, and ALP at first week.
Gut-Microbiome Composition
Change of the species and proportions of the gut microbiome. Proportion of phyrum level Composition of F/B ratio
Time frame: Change from Baseline of fecal microbiome at 8 months
Computed Tomography
change of the Abdominal ultrasonography or Computed Tomography(CT): Upper abdominal ultrasound or CT to determine the degree of fatty liver disease ② Fibroscan: Objectively and quantitatively grasp the degree of liver fibrosis by measuring the degree of firmness (elasticity) of the liver
Time frame: Change from Baseline of CT image at 8 months
change of BMI
Compare the body mass index. BMI=Body Weight/(Height)\^2
Time frame: Change from Baseline BMI and weight at 6 months
Secondary Outcomes; Liver Function Test
Secondary outcomes of liver function enzyme level (AST, ALT, rGT, CHOL, ALP)\[IU/L\]
Time frame: Change from Baseline of AST, ALT, rGT, CHOL, and ALP at 8 months
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