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Non Alcoholic Fatty Liver DiseaseNCT07378280

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

A study testing Probiotics (L. lactis CKDB001) in people with Non Alcoholic Fatty Liver Disease, run by Chuncheon Sacred Heart Hospital at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 19 to 75 years
Conditions the study is for
Non Alcoholic Fatty Liver Disease
What is being tested?
Probiotics (L. lactis CKDB001)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
95 participants
Where
1 siteSouth Korea
Study dates
18 Aug 2021to 24 Nov 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Hallym University Chuncheon Sacred Heart Hospital

    Chuncheon, Gangwon-do, 24210

Other trials in South Korea

About this study

Official title: 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

Being tested
Probiotics (L. lactis CKDB001), Placebo
Keywords
Non Alcoholic Fatty Liver, Probiotics, Gut-Liver Axis
Medical subject headings
Non-alcoholic Fatty Liver Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Probiotics (L. lactis CKDB001)Dietary supplement

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

  • PlaceboDietary supplement

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

Study groups in NCT07378280
Study groupRoleWhat they receive
PlaceboPlacebo comparatorThe 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.
Receives: Dietary Supplement: Placebo
L. lactis CKDB001ExperimentalThe 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.
Receives: Dietary Supplement: Probiotics (L. lactis CKDB001)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: From baseline to 12 weeks

Secondary outcomes (16)

  1. 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.

    Measured: From baseline to 12 weeks

  2. 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.

    Measured: From baseline to 12 weeks

  3. 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.

    Measured: From baseline to 12 weeks

  4. 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.

    Measured: From baseline to 12 weeks

  5. Changes in fasting plasma glucose levels (mg/dL)

    Change from baseline to 12 weeks in fasting plasma glucose levels will be assessed.

    Measured: From baseline to 12 weeks

  6. Changes in fasting serum insulin levels (μU/mL)

    Change from baseline to 12 weeks in fasting serum insulin levels will be assessed.

    Measured: From baseline to 12 weeks

  7. Changes in insulin resistance index: HOMA-IR

    Change from baseline to 12 weeks in the insulin resistance index (HOMA-IR) will be assessed.

    Measured: From baseline to 12 weeks

  8. 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.

    Measured: From baseline to 12 weeks

  9. 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.

    Measured: From baseline to 12 weeks

  10. 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.

    Measured: From baseline to 12 weeks

  11. 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.

    Measured: From baseline to 12 weeks

  12. Changes in body weight (kg)

    Change from baseline to 12 weeks in body weight will be assessed.

    Measured: From baseline to 12 weeks

  13. Changes in body mass index (kg/m²)

    Change from baseline to 12 weeks in body mass index will be assessed.

    Measured: From baseline to 12 weeks

  14. Changes in waist circumference (cm)

    Change from baseline to 12 weeks in waist circumference will be assessed.

    Measured: From baseline to 12 weeks

  15. Changes in hip circumference (cm)

    Change from baseline to 12 weeks in hip circumference will be assessed.

    Measured: From baseline to 12 weeks

  16. Changes in waist-to-hip ratio (WHR)

    Change from baseline to 12 weeks in waist-to-hip ratio will be assessed.

    Measured: From baseline to 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jan 2026
  2. Study start18 Aug 2021
  3. Primary completion2 Aug 2023
  4. Study completion24 Nov 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
95 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07378280
Sponsor's protocol ID
CKDB001-01
Status last verified
Jan 2026
First submitted
20 Oct 2024
Last updated
30 Jan 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Probiotics (L. lactis CKDB001) in people with Non Alcoholic Fatty Liver Disease, run by Chuncheon Sacred Heart Hospital at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in liver function parameters: AST (U/L), ALT (U/L) (time frame: From baseline to 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07378280.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2026.

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