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

NCT07378280 | Completed DMC

• 1 other identifier: CKDB001-01
• Study Type: interventional
• Target: 95
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Non Alcoholic Fatty Liver Disease

Keywords

Non Alcoholic Fatty Liver; Probiotics; Gut-Liver Axis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (16)

• Changes in liver function parameters: γ-GTP (U/L), ALP (U/L)

  From baseline to 12 weeks

• Changes in bilirubin parameters: Total bilirubin (mg/dL), Direct bilirubin (mg/dL)

  From baseline to 12 weeks

• Changes in protein parameters: Total protein (g/dL), Albumin (g/dL), Globulin (g/dL)

  From baseline to 12 weeks

• Changes in lipid parameters: Total cholesterol (mg/dL), LDL-C (mg/dL), HDL-C (mg/dL), Triglycerides (mg/dL)

  From baseline to 12 weeks

• Changes in fasting plasma glucose levels (mg/dL)

  From baseline to 12 weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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

L. lactis CKDB001

EXPERIMENTAL

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)

Interventions

Probiotics (L. lactis CKDB001) DIETARY_SUPPLEMENT

L. lactis CKDB001: Enteric coated capsule with L. lactis CKDB001, daily, 12 weeks

L. lactis CKDB001

Placebo DIETARY_SUPPLEMENT

Placebo: Enteric coated capsule without any probiotics, daily, 12 weeks

Placebo

Eligibility Criteria

• Age: 19 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Chong Kun Dang Bio: collaborator
• Chuncheon Sacred Heart Hospital: lead

Study Sites (1)

Hallym University Chuncheon Sacred Heart Hospital

Chuncheon, Gangwon-do, 24210, South Korea

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2024
• First Posted: January 30, 2026
• Study Start: August 18, 2021
• Primary Completion: August 2, 2023
• Study Completion: November 24, 2023
• Last Updated: January 30, 2026

Record last verified: 2026-01

Locations

KR (1)