Metabolic Dysfunction-Associated Steatotic Liver DiseaseNCT06873165
Development of Microbial Therapeutics for Metabolic-associated Fatty Liver Disease: From Mechanistic Investigations to Clinical Trials
A study testing Probiotics in people with Metabolic Dysfunction-Associated Steatotic Liver Disease, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
The goal of this clinical trial is to investigate the efficacy and safety of pasteurized Akkermansia muciniphila strain NTUH_Amuc03 (pAKK NTUH_Amuc03) in Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)Patients. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Metabolic Dysfunction-Associated Steatotic Liver Disease
- What is being tested?
- Probiotics
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteTaiwan
- Study dates
- 22 Jan 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 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.
- The subject is diagnosed through FibroScan (CAP≧ 260 db/m)and meets one of below .
- the subject's BMI ≧23 kg/m² or waist ≧ 90cm (male) 80cm (Female)
- Fasting glucose≧100 mg/dL or sugar after meal ≧140 mg/dL or HbA1c≧5.7 or diagnosed type II diabetes(including under treatment or not)
- Blood pressure≧ 130/80 mmHg or under medication.
- Blood Triglycerides≧150 mg/dL or under medication.
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- Blood HDL ≤ 40 mg/dL (Male) ≤ 50 mg/dL (Female) or under medication.
- If the subject is reproductive women, she should agree to take more than two ways of contraceptive methods.
- 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.
Who cannot join
- The subject is pregnant or lactating.
- The subject has received probiotics or prebiotics 14 days prior to visit 1.
- The subject has received any antibiotic (excluding topical agents) or antifungals within 30 days prior to visit 1.
- The subject has received medication affecting evaluating indicators 14 days prior to visit 1, including steroids, immunosuppressant or anti-inflammation drugs hepatitis and lipid, metabolism related compounds, but excluding the following medicines: Statins, Fibrates, Silymarin, Thiazolidinediones, Metformin, Fibrate, Cholestyramine, Ezetimibe, Orlistat, SGLT2i and GLP1-RAs.
- If the above-mentioned drugs are used continuously for more than six months and the dosage is not changed during the trial,this situation is accepted.
- The subject has a clinically significant, currently active or underlying diarrhea (loose stools more than three times in 24 hours) of infectious etiologies.
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- The subject who has been diagnosed a severe/injury hepatic disease, disease affecting liver function, active inflammatory bowel disease.
- Acute hepatitis caused by viruses or other causes and ALT > 200 U/L.
- Coronary artery disease with arterial stent surgery in half year.
- Fasting glucose≥ 300 mg/dl or HbA1c>9%.
- Blood 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 been aboard for 10 days within 60 days prior to visit 1, or plans to go aboard during this study.
- The subject is special diet.
- The subject is considered by the investigator as not suitable for the trial.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, Taiwan
Ming-Shiang Wu, M.D., Ph.D., +886-2-2312-3456, mingshiang@ntu.edu.tw
Chun-Jen Liu, M.D., Ph.D., +886-2-2312-3456, cjliu@ntu.edu.tw
About this study
The goal of this clinical trial is to investigate the efficacy and safety of pasteurized Akkermansia muciniphila strain NTUH_Amuc03 (pAKK NTUH_Amuc03) in Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)Patients. The main question it aims to answer is:
Does pAKK NTUH_Amuc03 trend to reduce the body weight, improve abnormal blood lipids , NASLD activity score, and HOMA-IR ?
Researchers will compare pAKK NTUH_Amuc03 to a placebo (a look-alike substance that contains no Akk) to see if pAKK NTUH_Amuc03 works to MASLD.
Participants will:
- Take capsule with pAKK NTUH_Amuc03 or a placebo every day for 3 months
- Visit the clinic once every 4 weeks for checkups and tests
Read the detailed description
Metabolic Dysfunction-Associated Steatotic Liver Disease(MASLD)is an improved diagnostic standard derived from Non-Alcoholic Fatty Liver Disease (NAFLD), emphasizing the correlation between fatty liver and metabolic dysfunction. Compared to NAFLD, which requires the exclusion of various conditions for diagnosis, the diagnostic criteria for MASLD can enhance the homogeneity of study subjects. It also addresses various groups with coexisting liver diseases, aiding in the efficiency and applicability of new drug development. MASLD has a prevalence rate of approximately one-fourth of the global population. If left untreated and worsens, it may lead to liver fibrosis, cirrhosis, or even liver cancer. Due to the significant medical burden associated with MASLD and the lack of FDA-approved treatments, the development of therapeutic methods for MASLD is an urgent issue. Past literature indicates that diet and gut microbiota play crucial roles in the progression of MASLD. The composition of the diet affects gut microbiota and intestinal barrier function. In cases of dysbiosis, harmful substances produced by gut microbiota, including pathogen-associated molecular patterns (PAMPs) and microbiota-dependent metabolites (MDMs), enter the liver through the portal vein via the leaky gut, resulting in toxicity. The pathogenic pathways exacerbating MASLD through gut microbiota dysbiosis, collectively termed the gut-liver axis, are not fully understood. Some animal studies have found dietary supplements to regulate gut microbiota beneficial for improving MASLD. Although most lack clinical evidence, incorporating food components that regulate gut microbiota and immune function into the diet indeed holds potential for treating MASLD. Next-generation probiotics have been found in past studies to improve liver lipid metabolism and regulate gut microbiota. They may slow the progression of MASLD by modulating the gut-liver axis. Previous studies by our team applied the pasteurized Akkermansia muciniphila strain NTUH_Amuc03 (pAKK NTUH_Amuc03), in preclinical animal studies to alleviate fatty liver disease progression. In experiments with mice induced with high-fat, high-fructose, high-cholesterol diets, pAKK NTUH_Amuc03 trended to reduce the body weight, improve abnormal blood lipids in mice, NASLD activity score, and HOMA-IR. These results indicate the potential of pAKK NTUH_Amuc03 to slow the progression of MASLD. Therefore, this project aims to further evaluate the efficacy and safety of pAKK NTUH_Amuc03 in MASLD patients through clinical trials.
- Being tested
- Probiotics, Placebo
- Keywords
- Metabolic Dysfunction-Associated Steatotic Liver Disease, Akkermansia muciniphila
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbioticsDietary supplement
Also called Akkermansia muciniphila
1 capsule(with three different dosage) per day for 12 weeks
PlaceboDietary supplement
1 capsule per day for 12weeks
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | 1 capsule per day for 12 weeks Receives: Dietary Supplement: Placebo |
| Active Comparator: AKK-1 | Active comparator | 1 capsule (with 1000000000 CFU pAKK LWHK0003) per day for 12 weeks Receives: Dietary Supplement: Probiotics |
| Active Comparator: AKK-2 | Active comparator | 1 capsule (with 10000000000 CFU pAKK LWHK0003) per day for 12 weeks Receives: Dietary Supplement: Probiotics |
| Active Comparator: AKK-3 | Active comparator | 1 capsule (with 100000000000 CFU pAKK LWHK0003) per day for 12 weeks Receives: Dietary Supplement: Probiotics |
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 sequencin
Measured: baseline and after 12-13th weeks
Improvement of intrahepatic fibrosis
evaluated by FibroScan
Measured: baseline 、 12th and 16th weeks
Secondary outcomes (2)
Changes in FIB-4
Fibrosis-4 (FIB-4) Index
Measured: baseline 、 12th and 16th weeks
Changes in gut permeability
evaluated by lactulose/mannitol ratio
Measured: baseline to 12th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2025
- Study start22 Jan 2025
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic Dysfunction-Associated Steatotic 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06873165
- Sponsor's protocol ID
- 202403035RSC
- Status last verified
- Jan 2025
- First submitted
- 6 Mar 2025
- Last updated
- 12 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Microbial Therapeutics for Metabolic-associated Fatty Liver Disease: From Mechanistic Investigations to Clinical Trials
- ClinicalTrials.gov ID
- NCT06873165
- Acronym / sponsor ID
- 202403035RSC
- Keywords
- Metabolic Dysfunction-Associated Steatotic Liver Disease, Akkermansia muciniphila
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 22 Jan 2025 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 12 Mar 2025 (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.
The goal of this clinical trial is to investigate the efficacy and safety of pasteurized Akkermansia muciniphila strain NTUH_Amuc03 (pAKK NTUH_Amuc03) in Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)Patients. The main question it aims to answer is:
Does pAKK NTUH_Amuc03 trend to reduce the body weight, improve abnormal blood lipids , NASLD activity score, and HOMA-IR ?
Researchers will compare pAKK NTUH_Amuc03 to a placebo (a look-alike substance that contains no Akk) to see if pAKK NTUH_Amuc03 works to MASLD.
Participants will:
- Take capsule with pAKK NTUH_Amuc03 or a placebo every day for 3 months
- Visit the clinic once every 4 weeks for checkups and tests
Detailed description
Metabolic Dysfunction-Associated Steatotic Liver Disease(MASLD)is an improved diagnostic standard derived from Non-Alcoholic Fatty Liver Disease (NAFLD), emphasizing the correlation between fatty liver and metabolic dysfunction. Compared to NAFLD, which requires the exclusion of various conditions for diagnosis, the diagnostic criteria for MASLD can enhance the homogeneity of study subjects. It also addresses various groups with coexisting liver diseases, aiding in the efficiency and applicability of new drug development. MASLD has a prevalence rate of approximately one-fourth of the global population. If left untreated and worsens, it may lead to liver fibrosis, cirrhosis, or even liver cancer. Due to the significant medical burden associated with MASLD and the lack of FDA-approved treatments, the development of therapeutic methods for MASLD is an urgent issue. Past literature indicates that diet and gut microbiota play crucial roles in the progression of MASLD. The composition of the diet affects gut microbiota and intestinal barrier function. In cases of dysbiosis, harmful substances produced by gut microbiota, including pathogen-associated molecular patterns (PAMPs) and microbiota-dependent metabolites (MDMs), enter the liver through the portal vein via the leaky gut, resulting in toxicity. The pathogenic pathways exacerbating MASLD through gut microbiota dysbiosis, collectively termed the gut-liver axis, are not fully understood. Some animal studies have found dietary supplements to regulate gut microbiota beneficial for improving MASLD. Although most lack clinical evidence, incorporating food components that regulate gut microbiota and immune function into the diet indeed holds potential for treating MASLD. Next-generation probiotics have been found in past studies to improve liver lipid metabolism and regulate gut microbiota. They may slow the progression of MASLD by modulating the gut-liver axis. Previous studies by our team applied the pasteurized Akkermansia muciniphila strain NTUH_Amuc03 (pAKK NTUH_Amuc03), in preclinical animal studies to alleviate fatty liver disease progression. In experiments with mice induced with high-fat, high-fructose, high-cholesterol diets, pAKK NTUH_Amuc03 trended to reduce the body weight, improve abnormal blood lipids in mice, NASLD activity score, and HOMA-IR. These results indicate the potential of pAKK NTUH_Amuc03 to slow the progression of MASLD. Therefore, this project aims to further evaluate the efficacy and safety of pAKK NTUH_Amuc03 in MASLD patients through clinical trials.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: Placebo1 capsule per day for 12 weeks |
| Active Comparator: AKK-1 | Active comparator | Dietary Supplement: Probiotics1 capsule (with 1000000000 CFU pAKK LWHK0003) per day for 12 weeks |
| Active Comparator: AKK-2 | Active comparator | Dietary Supplement: Probiotics1 capsule (with 10000000000 CFU pAKK LWHK0003) per day for 12 weeks |
| Active Comparator: AKK-3 | Active comparator | Dietary Supplement: Probiotics1 capsule (with 100000000000 CFU pAKK LWHK0003) per day for 12 weeks |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Male or female subjects aged between 20 and 70 years old.
- The subject is diagnosed through FibroScan (CAP≧ 260 db/m)and meets one of below .
- the subject's BMI ≧23 kg/m² or waist ≧ 90cm (male) 80cm (Female)
- Fasting glucose≧100 mg/dL or sugar after meal ≧140 mg/dL or HbA1c≧5.7 or diagnosed type II diabetes(including under treatment or not)
- Blood pressure≧ 130/80 mmHg or under medication.
Key exclusion criteria (16 listed)
- The subject is pregnant or lactating.
- The subject has received probiotics or prebiotics 14 days prior to visit 1.
- The subject has received any antibiotic (excluding topical agents) or antifungals within 30 days prior to visit 1.
- The subject has received medication affecting evaluating indicators 14 days prior to visit 1, including steroids, immunosuppressant or anti-inflammation drugs hepatitis and lipid, metabolism related compounds, but excluding the following medicines: Statins, Fibrates, Silymarin, Thiazolidinediones, Metformin, Fibrate, Cholestyramine, Ezetimibe, Orlistat, SGLT2i and GLP1-RAs.
- If the above-mentioned drugs are used continuously for more than six months and the dosage is not changed during the trial,this situation is accepted.
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 |
|---|---|---|
| ProbioticsAlso: Akkermansia muciniphila1 capsule(with three different dosage) per day for 12 weeks | Dietary supplement | Active Comparator: AKK-1, Active Comparator: AKK-2, Active Comparator: AKK-3 |
| Placebo1 capsule per day for 12weeks | Dietary supplement | Placebo |
Primary outcome
Changes in gut microbiota
Time frame: baseline and after 12-13th weeks
evaluated by fecal 16S rRNA gene sequencin
Improvement of intrahepatic fibrosis
Time frame: baseline 、 12th and 16th weeks
evaluated by FibroScan
2 secondary outcomes
Changes in FIB-4
Time frame: baseline 、 12th and 16th weeks
Changes in gut permeability
Time frame: baseline to 12th week
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2025.
- The globalization of nonalcoholic fatty liver disease: Prevalence and impact on world healthLink provided by the sponsor.
- Metabolic risk factors are associated with non-hepatitis B non-hepatitis C hepatocellular carcinoma in Taiwan, an endemic area of chronic hepatitis BLink provided by the sponsor.
- Global burden of NAFLD and NASH: trends, predictions, risk factors and preventionLink provided by the sponsor.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotics in people with Metabolic Dysfunction-Associated Steatotic Liver Disease, run by National Taiwan University Hospital at 1 site in Taiwan.
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 11 inclusion and 16 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: looking for participants now, as of the sponsor's last update on 12 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ming-Shiang Wu, M.D., Ph.D. (02-2312-3456, mingshiang@ntu.edu.tw), 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 and after 12-13th weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Mar 2025.