A study for evaluating the safety and efficacy of L. lactis CKDB001 on liver aminotransferases in subjects with nonalcoholic fatty liver disease
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Enrollment
95
L. lactis CKDB001: Enteric coated capsule with L. lactis CKDB001, daily, 12 weeks
Placebo: Enteric coated capsule without any probiotics, daily, 12 weeks
Hallym University Chuncheon Sacred Heart Hospital
Chuncheon, Gangwon-do, South Korea
Changes in liver function parameters: AST (U/L), ALT (U/L)
Change from baseline to 12 weeks in the specified liver function parameters will be assessed.
Time frame: From baseline to 12 weeks
Changes in liver function parameters: γ-GTP (U/L), ALP (U/L)
Change from baseline to 12 weeks in the specified liver function parameters will be assessed.
Time frame: From baseline to 12 weeks
Changes in bilirubin parameters: Total bilirubin (mg/dL), Direct bilirubin (mg/dL)
Change from baseline to 12 weeks in the specified bilirubin parameters will be assessed.
Time frame: From baseline to 12 weeks
Changes in protein parameters: Total protein (g/dL), Albumin (g/dL), Globulin (g/dL)
Change from baseline to 12 weeks in the specified protein parameters will be assessed.
Time frame: From baseline to 12 weeks
Changes in lipid parameters: Total cholesterol (mg/dL), LDL-C (mg/dL), HDL-C (mg/dL), Triglycerides (mg/dL)
Change from baseline to 12 weeks in the specified lipid parameters will be assessed.
Time frame: From baseline to 12 weeks
Changes in fasting plasma glucose levels (mg/dL)
Change from baseline to 12 weeks in fasting plasma glucose levels will be assessed.
Time frame: From baseline to 12 weeks
Changes in fasting serum insulin levels (μU/mL)
Change from baseline to 12 weeks in fasting serum insulin levels will be assessed.
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Time frame: From baseline to 12 weeks
Changes in insulin resistance index: HOMA-IR
Change from baseline to 12 weeks in the insulin resistance index (HOMA-IR) will be assessed.
Time frame: From baseline to 12 weeks
Changes in inflammatory markers: TNF-α (pg/mL), IL-6 (pg/mL), IL-10 (pg/mL)
Change from baseline to 12 weeks in the specified inflammatory cytokine markers will be assessed.
Time frame: From baseline to 12 weeks
Changes in high-sensitivity C-reactive protein levels (mg/L)
Change from baseline to 12 weeks in high-sensitivity C-reactive protein levels will be assessed.
Time frame: From baseline to 12 weeks
Changes in Fatigue Severity Scale (FSS)
Change from baseline to 12 weeks in Fatigue Severity Scale (FSS) score will be assessed. The FSS is a validated 9-item questionnaire with total scores ranging from 9 to 63, where higher scores indicate greater fatigue severity.
Time frame: From baseline to 12 weeks
Changes in gut environment assessed by metagenomics and metabolomics
Change from baseline to 12 weeks in gut environment will be assessed using metagenomic and metabolomic analyses.
Time frame: From baseline to 12 weeks
Changes in body weight (kg)
Change from baseline to 12 weeks in body weight will be assessed.
Time frame: From baseline to 12 weeks
Changes in body mass index (kg/m²)
Change from baseline to 12 weeks in body mass index will be assessed.
Time frame: From baseline to 12 weeks
Changes in waist circumference (cm)
Change from baseline to 12 weeks in waist circumference will be assessed.
Time frame: From baseline to 12 weeks
Changes in hip circumference (cm)
Change from baseline to 12 weeks in hip circumference will be assessed.
Time frame: From baseline to 12 weeks
Changes in waist-to-hip ratio (WHR)
Change from baseline to 12 weeks in waist-to-hip ratio will be assessed.
Time frame: From baseline to 12 weeks