Effects of Probiotics (P. Pentosaceus, L. Lactis or L. Helveticus) in NASH

February 17, 2026 updated by: Ki Tae Suk, Chuncheon Sacred Heart Hospital

Effects of Probiotics (P. Pentosaceus, L. Lactis or L. Helveticus) in Patients With Nonalcoholic Hepatitis

A study for evaluating the improvement effect on Metabolic dysfunction-associated steatotic liver disease (MASLD) of probiotics

Metabolic dysfunction-associated steatotic liver disease (MASLD) is associated with dysbiosis of the gut microbiota and altered host metabolic homeostasis. Probiotics have been proposed as a potential therapeutic strategy to modulate gut microbial composition and improve metabolic and hepatic outcomes in MASLD; however, clinical evidence regarding next-generation probiotic strains remains limited.

This study was designed to evaluate the effects of three next-generation probiotic strains-Lactobacillus delbrueckii subsp. lactis (LL001), Lactobacillus helveticus (LH001), and Pediococcus pentosaceus KID7 (PPKID7)-on liver function parameters and gut microbiome composition in patients with MASLD.

We conducted a randomized, double-blind, placebo-controlled, parallel-group clinical trial. A total of 110 adult patients diagnosed with MASLD were screened for eligibility. Eligible participants were randomly assigned to receive one of the three probiotic formulations (3 capsules per day, total 9×10⁹ CFU) or placebo for 8 weeks. All participants received concomitant silymarin during the intervention period.

Clinical assessments, serum samples, and stool samples were collected at baseline and at the end of the intervention. Liver function parameters were predefined as the primary outcome measure. Secondary outcomes included changes in anthropometric parameters, serum metabolic markers, gut microbiota composition assessed by 16S rRNA gene sequencing, and lipidomic profiles derived from serum and fecal samples. Compliance was monitored throughout the study period.

The study protocol was approved by the institutional review board, and written informed consent was obtained from all participants prior to enrollment.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Metabolic dysfunction-associated fatty liver disease applies to adults exhibiting hepatic steatosis identified through imaging techniques, blood biomarkers, or liver histology. This diagnosis is made in individuals who are overweight or obese, or who have type 2 diabetes mellitus, or at least two other metabolic risk abnormalities. Subsequently, in June 2023, a multi-society Delphi consensus statement was issued on a revised nomenclature for fatty liver diseases. This statement introduced the term metabolic dysfunction-associated steatotic liver disease (MASLD), effectively replacing the previous nonalcoholic fatty liver disease. Representative etiologies of MASLD are known to include insulin resistance, lipid toxicity due to excessive fat accumulation, inflammatory response, and endoplasmic reticulum stress.

The global rise in obesity has contributed to the increased prevalence of MASLD. MASLD affects approximately 30% of the global adult population, with its prevalence rising from 22% to 37% between 1991 and 2019. This increase aligns with the growing rates of obesity and related conditions worldwide. The more severe manifestation of MASLD, known as metabolic dysfunction-associated steatohepatitis (MASH), is histologically characterized by lobular inflammation and hepatocyte ballooning and is linked to a higher risk of fibrosis progression. Among individuals diagnosed with MASLD who do not meet criteria for a liver biopsy, the prevalence of MASH is approximately 7%. MASLD is one of the most common causes of chronic liver disease and liver-related death and serves as a risk factor for extrahepatic diseases such as diabetes and cardiovascular disease. As a result, the burden of social and economic costs caused by the disease is increasing.

Recently, interest in the role of the gut microbiome in the pathogenesis and treatment of liver diseases has increased, and the disease linkage caused by intestinal bacterial imbalance has been identified [16, 17]. Animal studies have demonstrated potential causal roles of the gut microbiota in MASLD [18, 19]. Human studies have described microbiome alterations in healthy individuals and patients with MASLD and have found several consistent specific taxa that differentiate between healthy individuals and patients with MASLD and advanced liver disease. Despite unknown mechanisms and lack of validation, therapeutic strategies utilizing the gut microbiome have the potential to provide beneficial effects in patients with MASLD.

Probiotics are live microorganisms that, when administered in adequate amounts, provide health benefits to the host. In our previous animal studies, Lactobacillus and Pediococcus supplementation improved MASLD by modulating gut microbiota and inflammation. Additional experiments with candidate strains have shown promising results in the prevention of MASLD progression. Several randomized controlled trials using ultrasonography and MASLD diagnostic markers of short duration have suggested that administration of probiotics may have a positive effect on hepatic steatosis and insulin resistance in patients. However, none of the previous studies reported the therapeutic effect of probiotics on the microbiome in patients with MASLD. In this clinical trial, we aimed to investigate whether administering probiotics for 8 weeks could effectively improve blood biochemical parameters and induce alterations in the gut microbiota among patients diagnosed with MASLD.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
89

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • South Korea
    • Gangwon-do
      • Chuncheon, Gangwon-do, South Korea, 200-704
        • Hallym University Chuncheon Sacred Heart Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

21 years to 62 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Those who agreed to participate in this study and signed a written consent
  2. Adult men and women over 20

  3. Patients diagnosed with non-alcoholic fatty liver

    ※ Exclusion criteria for alcoholic liver disease

    • Those who have an alcoholic drinking ability of at least 60g per day for at least one year before visiting (30g for women)
    • 1 bottle of shochu 360 ml * 20% = 72 g, 1 bottle of beer 500 ml (330 ml for commercial use) * 5% = 25 (16.5 g)

  4. Patients with higher liver numbers than normal ※ Adult normal liver level range by enzyme

    • AST, ALT: 40 or less
    • ALP: 20-130
    • GOT: 0-30, GPT: 0-38
    • GGT: 10-62 (male), 7-35 (female)

Exclusion Criteria:

  1. Those who have consumed probiotics (lactic acid bacteria, etc.), prebiotics (dietary fiber, fructooligosaccharide, etc.), new biotics, fermented milk, etc. within the past month.
  2. Those who have continuously taken antibiotics within the last 2 months or who are likely to take them during the study period
  3. Those who have continuously consumed medicines or health functional foods that affect liver function within the past month.
  4. Those who have participated in other clinical trials within the past 1 month (but not applicable to medical device clinical trials)

  5. If you have any of the following

    • Alcoholic liver disease, hereditary metabolic disease, autoimmune hepatitis
    • systemic inflammatory disease or immune disease
    • Hepatocellular carcinoma
    • Uncontrolled cardiopulmonary disease
    • Other serious systemic disorders in the heart, lungs, blood, and endocrine system
  6. A person with a history of malignancy diagnosis within the last 5 years
  7. Pregnant or lactating women
  8. Persons who have hypersensitivity to the test drug / placebo or components contained in the test drug / placebo or have severe allergic reactions
  9. Those who are not suitable for the clinical trial because the investigator judges

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Probiotics group
The selected test subjects were randomly assigned to test group 1, test group 2, test group 3, or control group according to the order registered at visit 2 (week 0) after a 2-week run-in period, and for 8 weeks, the study drug or study After taking the treaty, analyze the results of the observations.
Dietary supplement: Probiotics
  • 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
Other Names:
  • Cellulose (Placebo)
Placebo Comparator: Placebo group
The selected test subjects were randomly assigned to test group 1, test group 2, test group 3, or control group according to the order registered at visit 2 (week 0) after a 2-week run-in period, and for 8 weeks, the study drug or study After taking the treaty, analyze the results of the observations.
Dietary supplement: Probiotics
  • 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
Other Names:
  • Cellulose (Placebo)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Demographic characteristics
Time Frame: 1 week
The gender, date of birth, age, menstruation, and amenorrhea, FAMILY HISTORY
1 week
Primary Outcomes; Liver Function Test
Time Frame: Baseline of AST, ALT, rGT, CHOL, and ALP at first week.
Primary outcomes of liver function enzyme level (AST, ALT, rGT, CHOL, ALP)[IU/L]
Baseline of AST, ALT, rGT, CHOL, and ALP at first week.
Gut-Microbiome Composition
Time Frame: Change from Baseline of fecal microbiome at 8 months
Change of the species and proportions of the gut microbiome. Proportion of phyrum level Composition of F/B ratio
Change from Baseline of fecal microbiome at 8 months
Computed Tomography
Time Frame: Change from Baseline of CT image at 8 months

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
Change from Baseline of CT image at 8 months
change of BMI
Time Frame: Change from Baseline BMI and weight at 6 months
Compare the body mass index. BMI=Body Weight/(Height)^2
Change from Baseline BMI and weight at 6 months
Secondary Outcomes; Liver Function Test
Time Frame: Change from Baseline of AST, ALT, rGT, CHOL, and ALP at 8 months
Secondary outcomes of liver function enzyme level (AST, ALT, rGT, CHOL, ALP)[IU/L]
Change from Baseline of AST, ALT, rGT, CHOL, and ALP at 8 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Chuncheon Sacred Heart Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Chong Kun Dang Pharmaceutical

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 20, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 11, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 1, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 14, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 18, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 20, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 17, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PRO-NASH

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Personal data is regulated by IRB

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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