Impact of a Probiotic Supplementation With Lifestyle Modification on Liver Steatosis, Fibrosis, and Metabolic Health in Patients With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)

April 3, 2026 updated by: Fu Jen Catholic University Hospital

Impact of a Multi-strain Probiotic Supplementation With Lifestyle Modification on Liver Steatosis, Fibrosis, and Metabolic Health in Patients With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)

Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) is the new clinical term introduced in 2023 to redefine what was formerly known as Non-Alcoholic Fatty Liver Disease (NAFLD). It is defined as fatty liver confirmed by imaging or biopsy, accompanied by at least one cardiometabolic risk factor (e.g., hyperglycemia, dyslipidemia, hypertension, or obesity). Its pathological progression ranges from simple steatosis to steatohepatitis, primarily driven by excessive energy intake, hepatic lipid accumulation, and insulin resistance.

MASLD is currently the most prevalent chronic liver disease globally, with a prevalence rate of approximately 30-40%. However, there is no satisfactory pharmacological treatment, leaving lifestyle modification as the primary therapeutic approach. Many patients struggle to effectively adjust their habits, leading to persistent hepatic inflammation and damage, which may eventually progress to end-stage diseases such as cirrhosis and hepatocellular carcinoma. In many developed countries, MASLD has become the leading indication for liver transplantation, imposing a heavy burden on healthcare systems.

Gut dysbiosis is closely linked to MASLD. An imbalance in the gut microbiota disrupts the gut-liver axis, leading to impaired intestinal mucosal barrier function. This allows bacterial components to enter the circulation, further triggering hepatic inflammation and abnormal lipid metabolism. Consequently, modulating the gut microbiota is considered a potential therapeutic strategy.

Over the past decade, probiotics, prebiotics, and synbiotics have been extensively studied as non-pharmacological treatments for NAFLD. Multiple studies indicate that these products can reduce liver enzymes (AST, ALT), insulin resistance (HOMA-IR), and inflammatory markers (hs-CRP, TNF-α). The most effective combinations typically involve Lactobacillus, Bifidobacterium, and Streptococcus, with a recommended duration of approximately 12 weeks. However, the impact of these products on liver fibrosis, hepatic fat accumulation, and cardiometabolic risk factors remains inconclusive.

The probiotic product to be tested consists of Lactobacillus salivarius AP-32, Lactobacillus rhamnosus bv-77, Bifidobacterium animalis CP-9, and Lactobacillus reuteri GL-104. This formulation complies with food safety regulations. In clinical studies, it had been proven as an effective adjuvant method that increased beneficial gut bacteria such as Akkermansia muciniphila and improved the control of blood glucose, lipids, and inflammatory markers.

Study Objectives

This study aims to investigate the efficacy of this probiotic product as an adjuvant therapy alongside lifestyle modifications in adult patients with MASLD. We will evaluate its impact on:

  1. The degree of liver fibrosis and steatosis
  2. Cardiometabolic risk factors (BMI, waist circumference, blood lipids, and blood glucose).
  3. Inflammatory markers.
  4. Gut microbiota composition.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Not Applicable

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 Locations

  • Taiwan
      • New Taipei City, Taiwan
        • Recruiting
        • Fu Jen Catholic University Hospital
        • Contact:
      • New Taipei City, Taiwan
        • Not yet recruiting
        • Fu Jen Catholic University Hospital
        • Contact:

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

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • ALT ≥ 60 U/L
  • Liver steatosis identified by ultrasound

  • Meet at least one cardiometabolic criteria:

    1. BMI ≥ 25 kg/m2 (Asian ≥23)
    2. Waist circumference: > 94cm (M) 80cm(F)
    3. Fasting blood glucose ≥ 100 mg/dL
    4. HbA1c ≥ 5.7
    5. Receiving treatment of diabetes
    6. Receiving treatment of Hypertension
    7. Average home blood pressure: ≥ 130/85 mmHg
    8. TG ≥ 150 mg/dL
    9. HDL ≤ 40 mg/dL
    10. Receiving treatment of dyslipidemia

Exclusion Criteria:

  • HBsAg(+)
  • Anti-HCV (+)
  • Cirrhosis
  • Excessive alcohol intake ( Male over 210g/wk; Female over 140mg/wk)
  • Could not rule out Autoimmune hepatitis (ANA, or AMA or ASMA (+))
  • Could not rule out drug related hepatitis
  • Receiving drug that might induce liver steatosis:
  • Glucocorticoids
  • Amiodarone
  • Tamoxifen
  • Methotrexate
  • Valproate
  • Tetracycline
  • Chemotherapeutic agents
  • Receiving immune modulators or biologics
  • Receiving antibiotics within 1 month
  • Receiving any cancer treatment
  • Have diagnosis of "Catastrophic Illness" defined by Health Administration of Taiwan
  • eGFR<60
  • Pregnancy
  • Currently enrolled in other dietary or pharmacology clinical trial

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: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
Receive the probiotic product one sachet per day and standard lifestyle modification education for MASLD by a gastroenterologist.
Dietary supplement: Probiotic product
The probiotic product contains Lactobacillus salivarius AP-32, Lactobacillus rhamnosus bv-77, Bifidobacterium animalis CP-9 and Lactobacillus reuteri GL-104
Behavioral: Life style modification
Life style modification of MASLD provided by an gastroenterologist in an outpatient s
Active Comparator: Placebo
Receive the placebo one sachet per day and standard lifestyle modification education for MASLD by a gastroenterologist.
Behavioral: Life style modification
Life style modification of MASLD provided by an gastroenterologist in an outpatient s
Dietary supplement: placebo
placebo sachet looked and taste very similar to the probiotic product being tested

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in shear wave elastography (m/s) at 12 weeks
Time Frame: From enrollment to the end of treatment at 12 weeks
Change in liver fibrosis at 12 weeks
From enrollment to the end of treatment at 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in ultrasound attenuation coefficient (dB/cm/MHz) at 12 weeks
Time Frame: From enrollment to the end of treatment at 12 weeks
Change in liver steatosis at 12 weeks
From enrollment to the end of treatment at 12 weeks
Change in blood LDL level (mg/dL) at 12 weeks
Time Frame: From enrollment to the end of treatment at 12 weeks
Change in blood LDL level (mg/dL) at 12 weeks
From enrollment to the end of treatment at 12 weeks
Change in blood HDL level (mg/dL) at 12 weeks
Time Frame: From enrollment to the end of treatment at 12 weeks
Change in blood HDL level (mg/dL) at 12 weeks
From enrollment to the end of treatment at 12 weeks
Change in blood total cholesterol level (mg/dL) at 12 weeks
Time Frame: Time Frame: From enrollment to the end of treatment at 12 weeks
Change in blood total cholesterol level (mg/dL) at 12 weeks
Time Frame: From enrollment to the end of treatment at 12 weeks
Change in blood triglycerides level (mg/dL) at 12 weeks
Time Frame: From enrollment to the end of treatment at 12 weeks
Change in blood triglycerides level (mg/dL) at 12 weeks
From enrollment to the end of treatment at 12 weeks
Change in HOMA-IR at 12 weeks
Time Frame: From enrollment to the end of treatment at 12 weeks
Change in insulin resistance at 12 week
From enrollment to the end of treatment at 12 weeks
Change in blood fasting insulin level (μU/mL) at 12 weeks
Time Frame: From enrollment to the end of treatment at 12 weeks
From enrollment to the end of treatment at 12 weeks
Change in blood fasting glucose level (mg/dL) at 12 weeks
Time Frame: From enrollment to the end of treatment at 12 weeks
From enrollment to the end of treatment at 12 weeks
Change in blood AST level (U/L) at 12 weeks
Time Frame: From enrollment to the end of treatment at 12 weeks
Change in liver function test
From enrollment to the end of treatment at 12 weeks
Change in blood ALT level (U/L) at 12 weeks
Time Frame: From enrollment to the end of treatment at 12 weeks
Change in liver function test
From enrollment to the end of treatment at 12 weeks
Change in blood gamma-GT level (U/L) at 12 weeks
Time Frame: From enrollment to the end of treatment at 12 weeks
Change in liver function tests
From enrollment to the end of treatment at 12 weeks
Change in blood alkaline phosphatase level (IU/L) at 12 weeks
Time Frame: From enrollment to the end of treatment at 12 weeks
Change in liver function tests
From enrollment to the end of treatment at 12 weeks
Change in blood BUN level (mg/dL) at 12 weeks
Time Frame: From enrollment to the end of treatment at 12 weeks
Change in renal function
From enrollment to the end of treatment at 12 weeks
Change in blood Creatinine level (mg/dL) at 12 weeks
Time Frame: From enrollment to the end of treatment at 12 weeks
Change in renal functions
From enrollment to the end of treatment at 12 weeks
Change in eGFR level (mL/min/1.73m^2) at 12 weeks
Time Frame: From enrollment to the end of treatment at 12 weeks
Change in renal function
From enrollment to the end of treatment at 12 weeks
Change in blood albumin level (g/dL) at 12 weeks
Time Frame: From enrollment to the end of treatment at 12 weeks
Change in liver functions at 12 weeks
From enrollment to the end of treatment at 12 weeks
Change in platelet level (*10^3/uL) at 12 weeks
Time Frame: From enrollment to the end of treatment at 12 weeks
For the calculation of the chane of Fib-4 score at 12 weeks
From enrollment to the end of treatment at 12 weeks
Change in HbA1c level (%) at 12 weeks
Time Frame: From enrollment to the end of treatment at 12 weeks
Change in blood sugar control at 12 weeks
From enrollment to the end of treatment at 12 weeks
Change in blood hs-CRP level (mg/L) at 12 weeks
Time Frame: From enrollment to the end of treatment at 12 weeks
Change in systemic inflammation at 12 weeks
From enrollment to the end of treatment at 12 weeks
Change in blood IL-6 level (pg/mL) at 12 weeks
Time Frame: From enrollment to the end of treatment at 12 weeks
Change in systemic inflammation at 12 weeks
From enrollment to the end of treatment at 12 weeks
Change in blood TNF-alpha level (pg/mL) at 12 weeks
Time Frame: From enrollment to the end of treatment at 12 weeks
Change in systemic inflammation at 12 weeks
From enrollment to the end of treatment at 12 weeks
Change in Fib-4 score at 12 weeks
Time Frame: From enrollment to the end of treatment at 12 weeks
Change in liver fibrosis score at 12 weeks
From enrollment to the end of treatment at 12 weeks
Change in ARPI score at 12 weeks
Time Frame: From enrollment to the end of treatment at 12 weeks
Change in liver fibrosis score at 12 weeks
From enrollment to the end of treatment at 12 weeks
Change in NAFLD Fibrosis Score at 12 weeks
Time Frame: From enrollment to the end of treatment at 12 weeks
Change in liver fibrosis score at 12 weeks
From enrollment to the end of treatment at 12 weeks
Change in blood pressures (mmHg) at 12 weeks
Time Frame: From enrollment to the end of treatment at 12 weeks
From enrollment to the end of treatment at 12 weeks
Change in body weight (kg) at 12 weeks
Time Frame: From enrollment to the end of treatment at 12 weeks
From enrollment to the end of treatment at 12 weeks
Change in BMI (kg/m^2) at 12 weeks
Time Frame: From enrollment to the end of treatment at 12 weeks
From enrollment to the end of treatment at 12 weeks
Change in waist circumference (cm) at 12 weeks
Time Frame: From enrollment to the end of treatment at 12 weeks
From enrollment to the end of treatment at 12 weeks

Collaborators and Investigators

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

Sponsor

Fu Jen Catholic University Hospital

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)

April 1, 2026

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

August 1, 2027

Study Registration Dates

First Submitted

January 20, 2026

First Submitted That Met QC Criteria

February 3, 2026

First Posted (Actual)

February 10, 2026

Study Record Updates

Last Update Posted (Actual)

April 6, 2026

Last Update Submitted That Met QC Criteria

April 3, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FJUH114502

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

de-identification data

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

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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