Metabolic-related (nonalcoholic) fatty liver disease
Conditions
Interventions
Healthy Control Group:None
Experimental Group:Oral administration of probiotics
Sponsors
The First Affiliated Hospital of Nanchang University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1.Inclusion Criteria for Healthy Control Group Aged 18–70 years; No liver diseases, diabetes, obesity, or other metabolic disorders; Willingness to participate in the study and provision of signed informed consent. 2.Inclusion Criteria for MAFLD Group Phase 1: Age: 18–70 years. Diagnosis Criteria: Meets the diagnostic criteria outlined in the Chinese *Guidelines for the Prevention and Treatment of Metabolic (Non-alcoholic) Fatty Liver Disease (2024 Edition)*. Specifically, all three criteria must be fulfilled: (1) Imaging-based diagnosis of fatty liver and/or liver biopsy showing >=5% hepatic macrovesicular steatosis; (2) Presence of one or more components of metabolic syndrome; (3) Exclusion of other known causes of fatty liver, such as excessive alcohol consumption, malnutrition, Wilson's disease, etc. Controlled Attenuation Parameter (CAP): >=244 dB/m. Informed Consent: Willing to participate in the study and provision of signed informed consent. General Health: No severe systemic diseases (e.g., cardiac disease, liver or renal failure). The subject should be in generally good health and able to tolerate the probiotic intervention. Compliance Assessment: Expected to be able to complete all required intervention procedures and follow-up examinations with good compliance. Phase 2: Same as above.
Exclusion criteria
Exclusion criteria: 1.Exclusion Criteria for Healthy Control Group Use of antibiotics, probiotics, or receipt of fecal microbiota transplantation within the past 3 months; Severe dysfunction of the heart, lungs, kidneys, or other vital organs; Pregnancy or lactation. 2.Exclusion Criteria for the MAFLD Group Phase 1: Chronic liver disease due to other causes, such as viral hepatitis, HIV, autoimmune liver disease, as well as liver cirrhosis, end-stage liver disease, or hepatocellular carcinoma. Individuals who have used drugs known to be hepatotoxic, glucose-lowering drugs, probiotics, prebiotics, or have recently received antibiotic treatment within the 3 months prior to the study. Individuals with daily alcohol consumption exceeding 20 g/day for females or 30 g/day for males. Other exclusion criteria include: presence of gastrointestinal or psychiatric disorders, history of bariatric surgery, severe underlying diseases, pregnancy, or adherence to unconventional diets such as vegetarian, vegan, ketogenic, or extreme low-calorie diets. Phase 2: In addition to the exclusion criteria for the MAFLD group in Phase 1, individuals with "relatively high abundance of Akkermansia muciniphila (AKK) (abundance >=1.5%) as determined by 16S rRNA sequencing of the gut microbiota" are also excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Controlled Attenuation Parameter (CAP); | — |
Secondary
| Measure | Time frame |
|---|---|
| Magnetic resonance imaging-Proton density fat fraction, MRI-PDFF;Blood metabolites;Blood glucose;Liver Stiffness;Liver function;Renal Function;Abdominal Color Doppler Ultrasound;Blood lipids;Complete Blood Count;Gut microbiota; | — |
Countries
China
Contacts
Public ContactXiaoping Wu
The First Affiliated Hospital of Nanchang University
Outcome results
None listed