Probiotic Supplement Versus Placebo for the Treatment of Patients With Non-alcoholic Fatty Liver Disease

July 22, 2025 updated by: Phramongkutklao College of Medicine and Hospital

PROBIOTIC SUPPLEMENT VERSUS PLACEBO FOR DECREASE STEATOSIS IN METABOLIC DYSFUNCTION-ASSOCIATED STEATOTIC LIVER DISEASE (MASLD): A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL

Probiotic supplement versus placebo for the treatment of patients with non-alcoholic fatty liver disease: a randomized, double-blind, placebo-controlled trial

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Probiotic supplement versus placebo for the treatment of patients with non-alcoholic fatty liver disease: a randomized, double-blind, placebo-controlled trial by access liver biochemistry, MRI-PDFF, fibroscan and metabolic profile

Study Type

Interventional

Enrollment (Actual)

90

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 Locations

  • Thailand
      • Chiang Mai, Thailand, 50200
        • Chiangmai University
    • Bangkok
      • Ratchathewi, Bangkok, Thailand, 10400
        • Division of gastroenterology and hepatology

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

Yes

Description

Inclusion Criteria: Male and female adults ≥20,<80 years of age who suspected or confirmed diagnosis of NASH/NAFLD suggested by the historical data, they must meet one of the following criteria:

Fatty liver by imaging then fibroScan with CAP ≥ 248 dB m Liver biopsy compatible with NASH/NAFLD

Exclusion Criteria:

  1. Supplement with probiotic/prebiotic within 2 weeks
  2. Previous antibiotic/antifungus within 1 month
  3. History of significant alcohol consumption for a period of more than three consecutive months within 1 year before screening. Significant alcohol consumption is defined as equal to or greater than approximately two alcoholic drinks per day for males and approximately 1.5 alcoholic drinks per day for females
  4. Regular use of drugs historically associated with NAFLD, which include, but are not limited, to the following: amiodarone, methotrexate, systemic glucocorticoids at greater than 5 mg/d
  5. Chronic liver diseases from other cause such as viral hepatitis, autoimmune hepatitis

  6. Hepatic decompensation or impairment defined as presence of any of the following:

    • History of esophageal varices, ascites or hepatic encephalopathy.
    • Serum albumin <3.5 g dl-1, except as explained by nonhepatic causes.
    • INR > 1.4
  7. Use of GLP-1 agonist therapy (for example, exenatide, liraglutide, lixisenatide, albiglutide, dulaglutide, semaglutide and albiglutide), vitamin E and pioglitazone
  8. Active autoimmune disease, including actively treated lupus, rheumatoid arthritis, inflammatory bowel disease
  9. Active malignancy on treatment
  10. New York Heart Association Class III or IV heart failure or known left ventricular ejection fraction <30%
  11. Known immunocompromised status, HIV or who have recurrent or chronic systemic bacterial, fungal, viral or protozoal infections
  12. Respiratory compromised
  13. Severe renal impairment (eGFR <30 ml/min/1.73 m2)
  14. Pregnancy

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Maltodextrin in bovine gelatin capsule look same as probiotic (250 mg/capsule ) 2 capsule twice daily after breakfast and dinner
Dietary supplement: Placebo
placebo
Active Comparator: probiotic
Lactobacillus Zeae and Lactobacillus reuteri probiotic mixed with Maltodextrin in ratio 15:85 in bovine gelatin capsule (250 mg/capsule ) 2 capsule twice daily after breakfast and dinner (1,000 mg =1x109 CFU/g)
Dietary supplement: Probiotic
Probiotic-Lactobacillus Zeae and Lactobacillus reuteri

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Liver steatosis by MRI
Time Frame: 12 weeks
Hepatic steatosis with MRI-PDFF (the percent ratio of the density of mobile protons from triglycerides and the total density of protons from mobile triglycerides and mobile water). Outcome Measures was report as percent
12 weeks
Liver steatosis by fibroscan
Time Frame: 12 weeks
Shear wave velocity with controlled attenuation parameter (CAP) unit in decibels per meter (dB/m)
12 weeks
Liver stiffness by fibroscan
Time Frame: 12 weeks
Fibroscan- transient elastography in kilopascals (kPa)
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Liver inflammation
Time Frame: 12 weeks
Evaluated alanine aminotransferase (ALT; U/L), aspartate aminotransferase (AST; U/L), gamma-glutamyl transferase (GGT; U/L), and alkaline phosphatase (ALP; U/L)
12 weeks
Metabolic profile
Time Frame: 12 weeks
Fasting plasma glucose (FPG) in mg/dL
12 weeks
Metabolic profile
Time Frame: 12 weeks
HbA1C in percent
12 weeks
Metabolic profile: HOMA IR
Time Frame: 12 weeks
Fasting plasma glucose and serum insulin level will be combined to report in HOMA IR in mg/dl x mIU/L
12 weeks
Metabolic profile: serum lipid profiles
Time Frame: 12 weeks
Total cholesterol in mg/dL, low-density lipoprotein (LDL) cholesterol in mg/dL, high-density lipoprotein (HDL) in mg/dl, cholesterol in mg/dL, and triglyceride in mg/dL
12 weeks
Inflammatory marker
Time Frame: 12 weeks
hsCRP level in mg/L
12 weeks
Inflammatory marker
Time Frame: 12 weeks
Interleukin 6 (IL-6) in pg/mL
12 weeks
Anthropomorphic evaluation: BMI
Time Frame: 12 weeks
Weight and height will be combined to report BMI in kg/m^2
12 weeks
Anthropomorphic evaluation: composition analysis
Time Frame: 12 weeks
Body fat in percentage
12 weeks
Anthropomorphic evaluation
Time Frame: 12 weeks
Body muscle in kilogram
12 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fecal SCFA
Time Frame: 12 weeks
Fecal SCFA (acetate, propionate and butyrate) in microgram/ml metagenomic sequencing (Next-generation sequencing)
12 weeks

Collaborators and Investigators

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

Sponsor

Phramongkutklao College of Medicine and Hospital

Collaborators

Chiang Mai University
Thailand Institute of scientific and technological research

Investigators

  • Principal Investigator: Natchaporn Noppacroh, phramongkutklao

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)

July 25, 2024

Primary Completion (Actual)

April 22, 2025

Study Completion (Actual)

May 28, 2025

Study Registration Dates

First Submitted

June 16, 2024

First Submitted That Met QC Criteria

June 30, 2024

First Posted (Actual)

July 9, 2024

Study Record Updates

Last Update Posted (Actual)

July 25, 2025

Last Update Submitted That Met QC Criteria

July 22, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PMK GI 001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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