Non-Alcoholic Fatty Liver Disease Clinical Trial
Official title:
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
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.
Status | Not yet recruiting |
Enrollment | 30 |
Est. completion date | December 31, 2024 |
Est. primary completion date | April 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years to 70 Years |
Eligibility | Inclusion Criteria: - 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. Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
National Taiwan University Hospital | Taipei Medical University Hospital |
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Changes in gut microbiota | evaluated by fecal 16S rRNA gene sequencing | baseline to 8th, 12th, 16th and 24th weeks | |
Primary | Improvement of intrahepatic fibrosis | evaluated by FibroScan | baseline to 16th and 24th weeks | |
Primary | Changes in hepatic steatosis composition | evaluated by MRI-PDFF and MRI-MRS | baseline to 16th week | |
Secondary | Changes in FIB-4 | Fibrosis-4 (FIB-4) Index | baseline to 12th, 16th and 24th weeks | |
Secondary | Changes in gut permeability | evaluated by lactulose/mannitol ratio | baseline to 16th week |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05480696 -
Soluble Fibre Supplementation in NAFLD
|
Phase 1 | |
Active, not recruiting |
NCT02500147 -
Metformin for Ectopic Fat Deposition and Metabolic Markers in Polycystic Ovary Syndrome (PCOS)
|
Phase 4 | |
Completed |
NCT04671186 -
Role of Probiotics in Treatment of Pediatric NAFLD Patients by Assessing With Fibroscan
|
N/A | |
Recruiting |
NCT05979779 -
Ph 2 Study of the Safety and Efficacy of Three HU6 Dose Levels and Placebo in Nonalcoholic Steatohepatitis
|
Phase 2 | |
Recruiting |
NCT05462353 -
Study to Evaluate the Safety, Tolerability, and Efficacy of ASC41 Tablets in Adult Patients With NASH
|
Phase 2 | |
Completed |
NCT05006885 -
ALT-801 in Diabetic and Non-Diabetic Overweight and Obese Subjects With Non-alcoholic Fatty Liver Disease (NAFLD)
|
Phase 1 | |
Completed |
NCT04117802 -
Effects of Maple Syrup on Gut Microbiota Diversity and Metabolic Syndrome
|
N/A | |
Recruiting |
NCT04365855 -
The Olmsted NAFLD Epidemiology Study (TONES)
|
N/A | |
Recruiting |
NCT05618626 -
Prevention of NAFLD and CVD Through Lifestyle Intervention
|
N/A | |
Completed |
NCT03256526 -
6-week Safety and PD Study in Adults With NAFLD
|
Phase 2 | |
Enrolling by invitation |
NCT06152991 -
Clinical Trial Assessing Godex Carnitine Orotate Complex in Nonalcoholic Fatty Liver Disease Patients for Efficacy
|
Phase 3 | |
Completed |
NCT03681457 -
Evaluation of the Pharmacokinetics of Tropifexor in Subjects With Mild, Moderate, or Severe Hepatic Impairment Compared to Healthy Control Subjects
|
Phase 1 | |
Completed |
NCT06244550 -
Clinical Trials Using HepatoKeeper Herbal Essentials to Treat Non-alcoholic Fatty Liver Disease and Metabolic Factors
|
N/A | |
Not yet recruiting |
NCT05120557 -
Point-of-care Ultrasound Screening and Assessment of Chronic Liver Diseases and NASH
|
N/A | |
Completed |
NCT03060694 -
Screening Diabetes Patients for NAFLD With Controlled Attenuation Parameter and Liver Stiffness Measurements
|
||
Completed |
NCT02526732 -
Hepatic Inflammation and Physical Performance in Patients With NASH
|
N/A | |
Recruiting |
NCT01988441 -
The Influence of Autophagy on Fatty Liver
|
||
Recruiting |
NCT01680003 -
Hepar-P Study to Evaluate the Safety and Efficacy of a Standardised Extract of Phyllanthus Niruri for the Treatment of Non-alcoholic Fatty Liver Disease
|
Phase 2 | |
Completed |
NCT01712711 -
Helicobacter Pylori Eradication in Diabetic Subjects With Non-alcoholic Fatty Liver Disease
|
Phase 2 | |
Recruiting |
NCT00941642 -
Placebo Controlled Study Using Lovaza as Treatment for Non-Alcoholic Fatty Liver Disease
|
Phase 4 |