Development of Microbial Therapeutics for Metabolic-associated Fatty Liver Disease: From Mechanistic Investigations to Clinical Trials
NCT ID: NCT06873165
Last Updated: 2025-03-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
40 participants
INTERVENTIONAL
2025-01-22
2026-12-31
Brief Summary
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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:
1. Take capsule with pAKK NTUH\_Amuc03 or a placebo every day for 3 months
2. Visit the clinic once every 4 weeks for checkups and tests
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Placebo
1 capsule per day for 12 weeks
Placebo
1 capsule per day for 12weeks
Active Comparator: AKK-1
1 capsule (with 1000000000 CFU pAKK LWHK0003) per day for 12 weeks
Probiotics
1 capsule(with three different dosage) per day for 12 weeks
Active Comparator: AKK-2
1 capsule (with 10000000000 CFU pAKK LWHK0003) per day for 12 weeks
Probiotics
1 capsule(with three different dosage) per day for 12 weeks
Active Comparator: AKK-3
1 capsule (with 100000000000 CFU pAKK LWHK0003) per day for 12 weeks
Probiotics
1 capsule(with three different dosage) per day for 12 weeks
Interventions
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Probiotics
1 capsule(with three different dosage) per day for 12 weeks
Placebo
1 capsule per day for 12weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
* 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.
Exclusion Criteria
* 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.
* 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.
18 Years
70 Years
ALL
No
Sponsors
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National Taiwan University Hospital
OTHER
Responsible Party
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Locations
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National Taiwan University Hospital
Taipei, , Taiwan
Countries
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Central Contacts
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Facility Contacts
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Related Links
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The globalization of nonalcoholic fatty liver disease: Prevalence and impact on world health
Metabolic risk factors are associated with non-hepatitis B non-hepatitis C hepatocellular carcinoma in Taiwan, an endemic area of chronic hepatitis B
Global burden of NAFLD and NASH: trends, predictions, risk factors and prevention
Other Identifiers
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202403035RSC
Identifier Type: -
Identifier Source: org_study_id
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