NCT05686174

Investigation on Safety and Efficacy of Soybean Fermented Extract (MBS217) in Treating Patients With NAFLD

Investigation on Safety and Efficacy of Soybean Fermented Extract (MBS217) in Treating Patients With Non-alcoholic Fatty Liver Disease: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Study in National Taiwan University Hospital

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: National Taiwan University Hospital · Academic / Other
• Sex: All
• Age: 20 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Investigators aimed to investigate the efficacy and safety of fermented soybean extract (MBS-217) in treating participants with Non-alcoholic fatty liver disease (NAFLD) in this study.

Detailed description

Background: NAFLD is one of the most prevalent chronic liver diseases in Taiwan. NAFLD can progress to fibrosis, cirrhosis, and even liver cancer. Based on the current trend in epidemiology, fatty liver disease is forecasted to be the leading cause of liver transplantation by 2030. Since NAFLD imposes a significant medical burden and there is no approved medication for NAFLD, developing an effective therapy for improving NAFLD is undoubtedly an unmet need. Diet and gut microbiota play pivotal roles in NAFLD progress. The composition of the gut microbiota and gut barrier function is affected by dietary factors, which cause pathophysiological impacts on the liver through the immune and metabolic communications between gut and liver, which is coined as the "gut-liver axis." Therefore, intervention with dietary products from probiotics and prebiotics may be an opportunity to develop effective therapy against NAFLD. In fact, current evidence has shown that fermented soybean products can modulate hepatic lipid metabolism and possess potential prebiotic activities. Also, our preliminary data have shown that MBS217 supplementation has the effects of modulating gut microbiota and regulating the hepatic inflammatory-related immune response in both nonalcoholic steatohepatitis (NASH) mice and healthy adult subjects. Objective: Investigators aimed to investigate the efficacy and safety of MBS217 in treating participants with NAFLD in this study. The changes in other metabolic parameters, gut microbiome, metabolomics, and gut permeability will also be investigated. Methods: Using a block randomization with a block size of 2 in a 1:1 ratio, 30 eligible adult subjects aged 20-70 years diagnosed with NAFLD will be randomized to receive one of the following regimens. This study plans to enroll 30 eligible adult subjects aged 20-70 years diagnosed with NAFLD. Enrolled subjects will be randomly assigned to receive 4 mL of either MBS217 or placebo (1:1) treatment for 16 weeks and then followed for 8 weeks, with assessment for NAFLD-related parameters, gut microbiome, metabolomics, and gut permeability. Outcome analysis: The primary outcome is the improvement of hepatic steatosis, fibrosis, stiffness, and FIB-4 evaluated by FibroScan or MRI. The secondary outcomes are the frequency of adverse events, the overall NAFLD-related parameters, gut microbiota, metabolomics, and gut permeability.

Conditions

• Non-Alcoholic Fatty Liver Disease

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	MBS217	Soybean Fermented Extract (MBS217)
DIETARY_SUPPLEMENT	Placebo	Without active ingredient

Timeline

• Start date: 2023-02-01
• Primary completion: 2024-04-30
• Completion: 2024-12-31
• First posted: 2023-01-17
• Last updated: 2023-01-17