Status:
RECRUITING
Development of Microbial Therapeutics for Metabolic-associated Fatty Liver Disease: From Mechanistic Investigations to Clinical Trials
Lead Sponsor:
National Taiwan University Hospital
Conditions:
Metabolic Dysfunction-Associated Steatotic Liver Disease
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief 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 L...
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 live...
Eligibility Criteria
Inclusion
- 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.
- 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
- 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.
- 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.
Key Trial Info
Start Date :
January 22 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06873165
Start Date
January 22 2025
End Date
December 31 2026
Last Update
March 12 2025
Active Locations (1)
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1
National Taiwan University Hospital
Taipei, Taiwan, Taiwan