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

GenieBiome

Status: Active, not recruiting

Conditions: Metabolic Dysfunction-Associated Fatty Liver Disease

Treatments: Dietary Supplement: G-NiiB synbiotics formula (SLP07); Dietary Supplement: Active placebo

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT06537882

MAFLD-RCT

Details and patient eligibility

About

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.

Full 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.

Enrollment: 54 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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54 participants in 2 patient groups, including a placebo group

Active arm

Active Comparator group

Description:

Subjects will take 1 sachet of G-NiiB synbiotics formula (SLP07) daily for 3 months

Treatment:

Dietary Supplement: G-NiiB synbiotics formula (SLP07)

Placebo arm

Placebo Comparator group

Description:

Subjects will take 1 sachet of active vitamin daily for 3 months

Treatment:

Dietary Supplement: Active placebo