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

NCT05686174 | Unknown Phase 1

• 1 other identifier: 202108126RIPB
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Non-Alcoholic Fatty Liver Disease

Outcome Measures

Primary Outcomes (3)

• Changes in gut microbiota

  evaluated by fecal 16S rRNA gene sequencing

  baseline to 8th, 12th, 16th and 24th weeks

• Improvement of intrahepatic fibrosis

  evaluated by FibroScan

  baseline to 16th and 24th weeks

• Changes in hepatic steatosis composition

  evaluated by MRI-PDFF and MRI-MRS

  baseline to 16th week

Secondary Outcomes (2)

• Changes in FIB-4

  baseline to 12th, 16th and 24th weeks

• Changes in gut permeability

  baseline to 16th week

Study Arms (2)

MBS-217

ACTIVE COMPARATOR

4 ml MBS-217 twice a day for 16 weeks

Dietary Supplement: MBS217

Placebo

PLACEBO COMPARATOR

4 ml MBS-217 placebo twice a day for 16 weeks

Dietary Supplement: Placebo

Interventions

MBS217 DIETARY_SUPPLEMENT

Soybean Fermented Extract (MBS217)

MBS-217

Placebo DIETARY_SUPPLEMENT

Without active ingredient

Placebo

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female subjects aged between 20 and 70 years old.
• Serum ALT of the subject is between 40-200 U/L.
• The subject is diagnosed as NAFLD through FibroScan (CAP \> 220 db/m).
• BMI of the subject is between 18.5-40 kg/m2.
• The subject is able to provide written informed consent by himself/herself and agrees to comply with all protocol requirements.
• The subject agrees to comply with the following two requirements:
• comply with all follow-up visit requirements according to the trial protocol. comply with all requirement regarding fecal samples collection, storage and delivery according to the trial protocol.
• If the subject is reproductive women, she should agree to take more than two ways of contraceptive methods.

You may not qualify if:

• The subject is pregnant or lactating.
• The subject has received any antibiotic (excluding topical agents), antifungals or antivirals within 30 days prior to visit 1.
• The subject has received any steroids (excluding topical agents), immunosuppressant or anti-inflammation drugs within 14 days prior to visit 1.
• The subject has received probiotics or prebiotics 14 days prior to visit 1.
• The subject has received medication affecting evaluating indicators, including hepatitis and lipid metabolism related compounds, but excluding the following medicines: Statins, Fibrates, Silymarin, N-Acetyl Cystein, Thiazolidinediones, Metformin, Fibrate, Cholestyramine, Ezetimibe, Orlistat, SGLT2i and GLP1-RAs.
• The subject has a clinically significant, currently active or underlying diarrhea (loose stools more than three times in 24 hours) of infectious etiologies.
• The subject who has been diagnosed a severe/injury hepatic disease, acute/chronic viral hepatitis B, acute/chronic viral hepatitis C, human immunodeficiency virus infection, disease affecting liver function, active inflammatory bowel disease, gastric ulcer, chronic kidney disease, kidney function repairmen, chronic gut inflammatory disease, coronary artery disease with arterial stent surgery in half year, cancer, autoimmune disease, fasting glucose≥ 300 mg/dl, HbA1c\>9%, or serum triglyceride≥ 500 mg/dl.
• The subject currently is participating in studies involving other investigational drugs, medical devices, functional foods, or cosmetic within 30 days prior to visit 1.
• The subject has participated in body weight control plan within 60 days prior to visit 1.
• The subject has an alcohol abuse problem.
• The subject has been aboard for 10 days within 60 days prior to visit 1, or plans to go aboard during this study.
• The subject has soybean allergy.
• The subject is vegetarian or special diet.
• The subject is considered by the investigator as not suitable for the trial.

Sponsors & Collaborators

• National Taiwan University Hospital: lead
• Taipei Medical University Hospital: collaborator

Related Publications (1)

• Huang SC, Su HJ, Kao JH, Tseng TC, Yang HC, Su TH, Chen PJ, Liu CJ. Clinical and Histologic Features of Patients with Biopsy-Proven Metabolic Dysfunction-Associated Fatty Liver Disease. Gut Liver. 2021 May 15;15(3):451-458. doi: 10.5009/gnl20218.

  PMID: 33431715 BACKGROUND

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Central Study Contacts

Wei-Kai Wu

CONTACT

+886233667316; weikaiwu0115@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2022
• First Posted: January 17, 2023
• Study Start: February 1, 2023
• Primary Completion: April 30, 2024
• Study Completion: December 31, 2024
• Last Updated: January 17, 2023

Record last verified: 2022-12