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)

NCT07400367 | Not Yet Recruiting DMC

• 1 other identifier: FJUH114502
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Liver Elastography; Liver Steatosis; Liver Function Test; Insulin Resistance; Cardiometabolic Risk Factors

Keywords

MASLD; Probiotics; Liver fibrosis; Liver steatosis

Outcome Measures

Primary Outcomes (1)

• Change in shear wave elastography (m/s) at 12 weeks

  Change in liver fibrosis at 12 weeks

  From enrollment to the end of treatment at 12 weeks

Secondary Outcomes (28)

• Change in ultrasound attenuation coefficient (dB/cm/MHz) at 12 weeks

  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

  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

  From enrollment to the end of treatment at 12 weeks

Study Arms (2)

Intervention

EXPERIMENTAL

Receive the probiotic product one sachet per day and standard lifestyle modification education for MASLD by a gastroenterologist.

Dietary Supplement: Probiotic product; Behavioral: Life style modification

Placebo

ACTIVE COMPARATOR

Receive the placebo one sachet per day and standard lifestyle modification education for MASLD by a gastroenterologist.

Behavioral: Life style modification; Dietary Supplement: placebo

Interventions

Probiotic product DIETARY_SUPPLEMENT

The probiotic product contains Lactobacillus salivarius AP-32, Lactobacillus rhamnosus bv-77, Bifidobacterium animalis CP-9 and Lactobacillus reuteri GL-104

Intervention

Life style modification BEHAVIORAL

Life style modification of MASLD provided by an gastroenterologist in an outpatient s

Intervention; Placebo

placebo DIETARY_SUPPLEMENT

placebo sachet looked and taste very similar to the probiotic product being tested

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ALT ≥ 60 U/L
• Liver steatosis identified by ultrasound
• Meet at least one cardiometabolic criteria:
• BMI ≥ 25 kg/m2 (Asian ≥23)
• Waist circumference: \> 94cm (M) 80cm(F)
• Fasting blood glucose ≥ 100 mg/dL
• HbA1c ≥ 5.7
• Receiving treatment of diabetes
• Receiving treatment of Hypertension
• Average home blood pressure: ≥ 130/85 mmHg
• TG ≥ 150 mg/dL
• HDL ≤ 40 mg/dL
• Receiving treatment of dyslipidemia

You may not qualify if:

• 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

Sponsors & Collaborators

• Fu Jen Catholic University Hospital: lead

Study Sites (1)

Fu Jen Catholic University Hospital

New Taipei City, Taiwan

Location

Related Publications (10)

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MeSH Terms

Conditions

Fatty Liver; Insulin Resistance; Liver Cirrhosis

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Kuan Wei Wu

CONTACT

+886-922-710-756; david800413@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2026
• First Posted: February 10, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: February 10, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

TW (1)