Study to Investigate the Effect of L. Lactis CKDB001 Administration on Liver Aminotransferases in Subjects With NAFLD

A Randomized, Double-blinded, Placebo-controlled, Multi-center Study to Investigate the Effect of L. Lactis CKDB001 Administration on Liver Aminotransferases in Subjects With Nonalcoholic Fatty Liver Disease

A study for evaluating the safety and efficacy of L. lactis CKDB001 on liver aminotransferases in subjects with nonalcoholic fatty liver disease

Study Overview

• Status: Completed
• Conditions: Non Alcoholic Fatty Liver Disease
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: Probiotics (L. lactis CKDB001)

• Study Type: Interventional
• Enrollment (Actual): 95
• Phase: Not Applicable

Contacts and Locations

Study Locations

• South Korea
  • Gangwon-do
    • Chuncheon, Gangwon-do, South Korea, 24210
      • Hallym University Chuncheon Sacred Heart Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adult men and women aged 19 to 75 years at the time of written consent
• Voluntarily provided written consent after receiving sufficient explanation about the study
• ALT or AST levels exceed the upper limit of normal, but are five times or less than the upper limit

Exclusion Criteria:

• Pregnant or breastfeeding women
• Women of childbearing potential and men who are unable or unwilling to use appropriate contraception during the study period
• Individuals with a history of alcohol abuse or chronic alcohol consumption:

Daily alcohol consumption averaging over 30g/day (210g/week) for men or over 20g/day (140g/week) for women

• Individuals with viral or other liver diseases that could affect study results:
• Individuals with a history of or current drug abuse
• Individuals with a history of psychiatric disorders or current psychiatric conditions that may interfere with the study
• Individuals with a history of major gastrointestinal surgery (excluding appendectomy, but including gastric resection, gastrointestinal bypass, anastomosis, bariatric metabolic surgeries)
• Individuals with severe comorbidities that make them unsuitable for study participation (e.g., heart disease, kidney disease, malignancy, immunosuppression, etc.):
• Regular consumption of probiotics, prebiotics, synbiotics, or fermented milk within 4 weeks prior to screening (participation allowed if consumption ceases at least 1 month before study start)
• Regular consumption of medications, health supplements, or herbal remedies that may affect liver function or anti-inflammatory responses within 4 weeks prior to screening (participation allowed if consumption ceases at least 1 month before study start)
• Use of medications that may cause hepatic steatosis (e.g., amiodarone, tamoxifen, methotrexate, tetracycline, corticosteroids)
• Use of medications for treating non-alcoholic fatty liver disease (NAFLD) or steatohepatitis (NASH) within 3 months prior to screening (e.g., thiazolidinediones, vitamin E)
• Use of medications that may affect study results (e.g., antipyretic analgesics, NSAIDs, anti-tuberculosis drugs, antibiotics, anticonvulsants, choleretics, liver disease medications)
• Use of oral steroids, hormones, or drugs that may affect absorption, metabolism, or excretion of food within 4 weeks prior to screening (participation allowed if taking systemic steroids or thyroid hormones in stable doses for ≥3 months before screening)
• Use of hypoglycemic agents or lipid-lowering drugs (except insulin or thiazolidinediones) with stable doses for at least 3 months prior to screening
• Dietary or exercise therapies that may affect study within 3 months prior to screening
• Smokers consuming more than 20 cigarettes per day
• Allergies or digestive issues related to study food ingredients
• Weight loss exceeding 10% of previous body weight within 6 months prior to screening
• Participation in another clinical trial within 30 days prior to screening or not completing the required five-half-life period of investigational drug/food from a previous trial
• Any other individuals deemed unsuitable for the study by the investigator

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; The selected test subjects were randomly assigned to placebo and L. lactis CKDB001 group according to the order registered at visit 2 (week 0) after a 2-week run-in period, and treated with placebo for 12 weeks. After treatment, primary and secondary outcomes were analyzed.	Dietary supplement: Placebo; Placebo: Enteric coated capsule without any probiotics, daily, 12 weeks
Experimental: L. lactis CKDB001; The selected test subjects were randomly assigned to placebo and L. lactis CKDB001 group according to the order registered at visit 2 (week 0) after a 2-week run-in period, and treated with L. lactis CKDB001 (5.0E+09 CFU/day) for 12 weeks. After treatment, primary and secondary outcomes were analyzed.	Dietary supplement: Probiotics (L. lactis CKDB001); L. lactis CKDB001: Enteric coated capsule with L. lactis CKDB001, daily, 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From baseline to 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	From baseline to 12 weeks
Changes in body weight (kg)	Change from baseline to 12 weeks in body weight will be assessed.	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.	From baseline to 12 weeks
Changes in waist circumference (cm)	Change from baseline to 12 weeks in waist circumference will be assessed.	From baseline to 12 weeks
Changes in hip circumference (cm)	Change from baseline to 12 weeks in hip circumference will be assessed.	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.	From baseline to 12 weeks

Collaborators and Investigators

• Sponsor: Chuncheon Sacred Heart Hospital
• Collaborators: Chong Kun Dang Bio

Study record dates

Study Major Dates

• Study Start (Actual): August 18, 2021
• Primary Completion (Actual): August 2, 2023
• Study Completion (Actual): November 24, 2023

Study Registration Dates

• First Submitted: October 20, 2024
• First Submitted That Met QC Criteria: January 22, 2026
• First Posted (Actual): January 30, 2026

Study Record Updates

• Last Update Posted (Actual): January 30, 2026
• Last Update Submitted That Met QC Criteria: January 22, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Probiotics; Gut-Liver Axis; Non Alcoholic Fatty Liver
• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease; Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Probiotics
• Other Study ID Numbers: CKDB001-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No