Non-Alcoholic Fatty Liver DiseasePhase 1NCT05686174
Investigation on Safety and Efficacy of Soybean Fermented Extract (MBS217) in Treating Patients With NAFLD
A Phase 1 study testing MBS217 in people with Non-Alcoholic Fatty Liver Disease, run by National Taiwan University Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Non-Alcoholic Fatty Liver Disease
- What is being tested?
- MBS217
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2023to 31 Dec 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 14Show fewer
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the 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
- Being tested
- MBS217, Placebo
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MBS217Dietary supplement
Soybean Fermented Extract (MBS217)
PlaceboDietary supplement
Without active ingredient
| Study group | Role | What they receive |
|---|---|---|
| MBS-217 | Active comparator | 4 ml MBS-217 twice a day for 16 weeks Receives: Dietary Supplement: MBS217 |
| Placebo | Placebo comparator | 4 ml MBS-217 placebo twice a day for 16 weeks Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in gut microbiota
evaluated by fecal 16S rRNA gene sequencing
Measured: baseline to 8th, 12th, 16th and 24th weeks
Improvement of intrahepatic fibrosis
evaluated by FibroScan
Measured: baseline to 16th and 24th weeks
Changes in hepatic steatosis composition
evaluated by MRI-PDFF and MRI-MRS
Measured: baseline to 16th week
Secondary outcomes (2)
Changes in FIB-4
Fibrosis-4 (FIB-4) Index
Measured: baseline to 12th, 16th and 24th weeks
Changes in gut permeability
evaluated by lactulose/mannitol ratio
Measured: baseline to 16th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2023
- Study start1 Feb 2023 (estimated)
- Primary completion30 Apr 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-Alcoholic Fatty Liver DiseaseStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Taipei Medical University Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05686174
- Sponsor's protocol ID
- 202108126RIPB
- Status last verified
- Dec 2022
- First submitted
- 21 Dec 2022
- Last updated
- 17 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 33431715
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05686174
- Acronym / sponsor ID
- 202108126RIPB
- Conditions
- Non-Alcoholic Fatty Liver Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Collaborators
- Taipei Medical University Hospital
- Study start
- 1 Feb 2023 (estimated)
- Primary completion
- 30 Apr 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 17 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MBS-217 | Active comparator | Dietary Supplement: MBS2174 ml MBS-217 twice a day for 16 weeks |
| Placebo | Placebo comparator | Dietary Supplement: Placebo4 ml MBS-217 placebo twice a day for 16 weeks |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MBS217Soybean Fermented Extract (MBS217) | Dietary supplement | MBS-217 |
| PlaceboWithout active ingredient | Dietary supplement | Placebo |
Primary outcome
Changes in gut microbiota
Time frame: baseline to 8th, 12th, 16th and 24th weeks
evaluated by fecal 16S rRNA gene sequencing
Improvement of intrahepatic fibrosis
Time frame: baseline to 16th and 24th weeks
evaluated by FibroScan
Changes in hepatic steatosis composition
Time frame: baseline to 16th week
evaluated by MRI-PDFF and MRI-MRS
2 secondary outcomes
Changes in FIB-4
Time frame: baseline to 12th, 16th and 24th weeks
Changes in gut permeability
Time frame: baseline to 16th week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2023.
- Background: PubMed 33431715Huang 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MBS217 in people with Non-Alcoholic Fatty Liver Disease, run by National Taiwan University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wei-Kai Wu (+886233667316, weikaiwu0115@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in gut microbiota (time frame: baseline to 8th, 12th, 16th and 24th weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05686174, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2023.