Metabolic-related fatty liver disease
Conditions
Interventions
Probiotic group:Take 2 sachets of specific trial product 1 time per day,A total of 12 weeks of intervention were held
Placebo group:Take 2 sachets of specific trial product 1 time per day,A total of 12 weeks of intervention were held
Healthy people group:None
Sponsors
Shenzhen Longgang Central Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Trial Group: 1) Age 18-65 years old (including boundary value), male or female and ethnicity are not limited; 2) Voluntarily participate in this clinical trial, be able to understand and sign the informed consent form, and be willing and able to comply with the planned visits and study procedures; 3) Patients diagnosed with MAFLD by clinicians according to the Guidelines for the Prevention and Treatment of Metabolic-related (Non-alcoholic) Fatty Liver Diseases (2024 Edition) of the Chinese Society of Hepatology Healthy Group : 1) Age 18-65 years old (including boundary value), male or female and ethnic group; 2) Healthy people, if they have other diseases, are currently in stable disease status and are in good overall physical condition; 3) Suitable to participate in this study after being assessed by the investigator; 4) Voluntarily participate in clinical trials and sign the informed consent form
Exclusion criteria
Exclusion criteria: Experimental Group: 1) Viral liver disease, alcoholic liver disease, autoimmune liver disease, Wilson's disease, biliary tract disease, liver cirrhosis and severe liver failure; 2) Patients with congenital heart disease, acute myocardial infarction, acute cerebral infarction and cerebral hemorrhage, severe arrhythmia, PCI postoperative, pulmonary heart disease, respiratory exhaustion, renal insufficiency (BUN or CR exceeds 1.5 times of the upper limit of the reference value), hematopoietic diseases, active infection and malignant tumors; 3) Long-term use of drugs that affect liver function (isoniazid, rifampicin, glibenclamide, gliquinolone, oral contraceptives, azathioprine, methotrexate, 5-fluorouracil, chlorpromazine, etc.); 4) Taking weight loss drugs, lipid-lowering drugs, hepatoprotective drugs or other Chinese and Western drugs that may cause liver enzymatic changes in the past 3 months; 5) Use of probiotic preparations, immunosuppressants, antibiotics and other drugs or foods that affect the intestinal flora within 1 month; 6) Pregnant, lactating or planning to conceive in the past 3 months; 7) Those with allergies or allergies to the known ingredients of the study food; 8) Have a major mental disorder, find it difficult to control their own actions, and are unable to cooperate with the study; 9) History of excessive alcohol consumption (ethanol equivalent > 30 g/d for men and 20 g/d >for women) Healthy Group: 1) Combined with other serious instrumental diseases or diseases in the acute attack stage; 2) Participated in other interventional clinical trials (including drugs, nutritional preparations, medical devices, etc.) 4 weeks before screening; 3) Other circumstances that the investigator considers inappropriate to participate in this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Transient elastography of the liver; | — |
Secondary
| Measure | Time frame |
|---|---|
| Five items of liver function;Six blood lipids;Inflammatory factors; | — |
Countries
China
Contacts
Public ContactQu Zhijun
Shenzhen Longgang Central Hospital
Outcome results
None listed