Evaluate the Effect of Synbiotics on MAFLD (MAFLD-RCT)

April 1, 2025 updated by: GenieBiome Limited

A Double-blind Randomized Placebo-controlled Study to Evaluate the Effect of Synbiotics SLP07 on Metabolic Dysfunction-Associated Fatty Liver Disease (MAFLD-RCT)

Non-alcoholic fatty liver disease (NAFLD) is one of the most common chronic liver diseases worldwide. Available data indicates that probiotics may regulate the gut microbiota, while Vitamin E and omega 3 are safe and effective at treating NAFLD patients. In this study, investigators aim to investigate if the enhanced synbiotic preparation of SLP07 is efficacious in liver function improvement in subjects with MAFLD.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Non-alcoholic fatty liver disease (NAFLD) is one of the most common chronic liver diseases worldwide.(1) The prevalence of NAFLD is estimated to be about 20%-30% in the Western world (2) and increasing in Asia. The prevalence of NAFLD across Asia varies from 5% to 40%.(3,4) The population prevalence of NAFLD in Hong Kong Chinese was 27.3%.(1) NAFLD may progress to non-alcoholic steatohepatitis (NASH), cirrhosis, liver failure and liver cancer, and is believed to be the leading etiology for cryptogenic cirrhosis.(5,6) NAFLD is also strongly associated with obesity and metabolic syndrome and is shown to be an independent cardiovascular risk factor.(7,8) Recently, a consensus by an international panel of experts recommended a change in name for NAFLD to metabolic dysfunction associated with fatty liver disease (MAFLD).(9) Patients who fulfil the MAFLD criteria have more severe metabolic and liver disease than those who fulfil the NAFLD criteria alone. At present, there is no standard pharmacologic therapy available for NAFLD or MAFLD currently.

Recently, it has been reported that NAFLD might be linked to small intestinal bacterial overgrowth (SIBO), which induces liver injury by gut-derived lipopolysaccharides (LPS) and TNF- α production. (10) Probiotics have several anti-inflammatory effects that can contribute to their clinical benefits in NAFLD.(11) Gut microbiota also plays a role in the development of insulin resistance, hepatic steatosis, necroinflammation and fibrosis. (12) The use of probiotics, prebiotics and synbiotics has been considered a potential and promising strategy to regulate the gut microbiota.(13,14) In the meantime, Vitamin E has been recommended for use in NAFLD treatmentand prevents liver injury. Moreover, many clinical trials and meta-analyses have evaluated the efficacy of omega 3 (C20-22 ω3 polyunsaturated fatty acids (PUFA)) in reducing existing NAFLD in adults and children, and the results indicate that omega 3 is safe and effective at lowering liver fat in NAFLD patients. (15,16)

In this study, investigators aim to investigate if the SLP07, which is an investigational product that contains a blend of naturally occurring food-grade Bifidobacterium and Lactobacillus strains, omega-3 and vitamin E, is efficacious in liver function improvement in subjects with MAFLD.

Study Type

Interventional

Enrollment (Actual)

54

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

  • Hong Kong
      • Hong Kong, Hong Kong
        • GenieBiome Limited

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:

  • Subjects with MAFLD with CAP ≥ 270 by fibroscan
  • Age ≥ 50
  • Subjects with diabetes or components of metabolic syndrome
  • Subjects have been taking stable medication 3 months prior to enrolment and are expected to remain stable throughout the study period
  • Written informed consent can be obtained

Exclusion Criteria:

  • Known history of any secondary causes of MAFLD including alcoholic liver disease, drug-induced liver injury, autoimmune hepatitis, viral hepatitis, cholestatic liver disease and metabolic/genetic liver disease
  • Active malignancy (on any kind of treatments for the known cancer)
  • Known diabetes with poor control (HbA1c > 8.5%) within 3 months
  • Significant alcohol consumption (over 10g per day: a half pint or half bottle of beer or a standard-size wine glass)
  • Subjects who are using insulin and Glucagon-like peptide-1(GLP1) such as dulaglutide, semaglutide
  • Consumption of systemic corticosteroids or methotrexate in the last 6 months
  • Use of antibiotics, probiotics or prebiotics one month prior to enrolment
  • Taking any supplements which are claimed to possibly protect the liver or improve liver functions including vitamin E and omega-3
  • Any condition or allergy history for probiotics
  • Any allergy to vitamin E, omega-3 or lactose

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: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Active arm
Subjects will take 1 sachet of G-NiiB synbiotics formula (SLP07) daily for 3 months
Dietary supplement: G-NiiB synbiotics formula (SLP07)
SLP07 consists of a blend of food-grade Bifidobacterium and Lactobacillus as active probiotics, omega 3, and vitamin E.
Placebo Comparator: Placebo arm
Subjects will take 1 sachet of active vitamin daily for 3 months
Dietary supplement: Active placebo
Active placebo contains 2mg of vitamin C with corn starch filler

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of participants with a reduction of at least 1 grade of steatosis AND/OR >10% reduction in CAP scores at 3 months
Time Frame: 3 months
The change of CAP score measured by fibroscan. CAP score is a measurement of fat accumulation in the liver to further determine the steatosis grade. The CAP score ranges from 100 to 400 decibels per meter (dB/m). The higher the score, the more the steatosis is.
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of body mass index (BMI) across the study period.
Time Frame: 3 months
The change of body weight and body height
3 months
Change of body waist circumference across the study period.
Time Frame: 3 months
The change of waist circumference
3 months
Percentage of participants with improvement in steatohepatitis across the study period.
Time Frame: 3 months
The percentage of improvement in steatohepatitis compared to the baseline
3 months
Change in lipid profile across the study period.
Time Frame: 3 months
The change in the level of lipid profiles
3 months
Adverse events reported during the study period.
Time Frame: 3 months
The adverse events reported throughout the study
3 months
Changes in faecal microbial profiling across 16 weeks
Time Frame: 3 months
The change of microbial profile in stool compared to baseline
3 months
Change of liver stiffness (measured in kPa) across the study period
Time Frame: 3 months
The change of liver stiffness (measured in kPa)
3 months
Change of CAP score across the study period
Time Frame: 3 months
CAP score is a measurement of fat accumulation in the liver to further determine the steatosis grade. The CAP score ranges from 100 to 400 decibels per meter (dB/m). The higher the score, the more the steatosis is.
3 months

Collaborators and Investigators

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

Sponsor

GenieBiome Limited

Collaborators

Microbiota I-Centre (MagIC)

Investigators

  • Study Director: Jessica Ching, PhD, GenieBiome Limited

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)

May 17, 2024

Primary Completion (Actual)

February 7, 2025

Study Completion (Estimated)

June 30, 2026

Study Registration Dates

First Submitted

July 29, 2024

First Submitted That Met QC Criteria

August 2, 2024

First Posted (Actual)

August 5, 2024

Study Record Updates

Last Update Posted (Actual)

April 3, 2025

Last Update Submitted That Met QC Criteria

April 1, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MAFLD-RCT

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.

Clinical Trials on Metabolic Dysfunction-Associated Fatty Liver Disease

Clinical Trials on G-NiiB synbiotics formula (SLP07)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Tunisia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe