Metabolic Associated Fatty Liver Disease
Conditions
Interventions
Experimental group:Rifaximin treatment
Control group:None
Sponsors
Shanghai Changzheng Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Willing to sign the informed consent form. 2. Aged 18 to 75 years, gender is not limited. 3. Patients with hepatic steatosis diagnosed by B-ultrasound (according to the NAFLD diagnosis and treatment guidelines in the Asia-Pacific region, those with two or more of the following abnormal findings on transabdominal ultrasonography can be diagnosed as fatty liver): (1) The near-field echo of the liver is enhanced, and the far-field echo is weakened; (2) The echo of liver parenchyma is dense and stronger than that of kidney parenchyma; (3) The structures of intrahepatic blood vessels and biliary tract are not clearly displayed. 4. There is less than one of the following metabolic abnormality criteria: overweight or obesity (BMI >= 23kg/m^2), type 2 diabetes (T2DM) or clinical evidence of metabolic dysfunction. Metabolic dysfunction refers to the presence of at least two of the following abnormal metabolic indicators: (1) The waist circumference of men is >= 90cm, and the waist circumference of women is >= 80cm. (2) Systolic/diastolic blood pressure >= 130/85mmHg, and (or) those who have been diagnosed with hypertension and treated. (3) Fasting plasma triglyceride >=1.7mmol/L (150mg/dl) or those who have been diagnosed and treated. (4) Fasting plasma HDL-C = 2.5. (7) Plasma high-sensitivity C-reactive protein (hs-CRP) > 2 mg/L.
Exclusion criteria
Exclusion criteria: 1. Patients with cirrhosis diagnosed by clinical, laboratory, imaging examination and/or liver biopsy; 2. Chronic liver disease with other etiologies confirmed by medical history or laboratory tests: viral (type B or C, etc.), autoimmune liver disease, alcoholic liver disease (more than 20g/day for women, more than 30g/day for men), drug-induced liver disease, hepatolenticular degeneration, antitrypsin-1 genetic deficiency and idiopathic hemochromatosis and other liver diseases; 3. Other causes of hepatic steatosis have been confirmed by medical history or laboratory tests; drugs (tamoxifen, amiodarone, sodium valproate, methotrexate, glucocorticoids, olanzapine), total Parenteral Nutrition, Hypothyroidism, Inflammatory Bowel Disease, Cushing's Syndrome, Celiac Disease, ß-Lipoprotein Deficiency, Lipid Atrophic Diabetes, Moriac Syndrome, anterior pituitary hypofunction, hypogonadism, polycystic ovary syndrome, etc.; 4. Use of drugs that alter intestinal flora in the past 4 weeks, such as lactulose, systemic antibiotics, various types of intestinal microecological preparations or cholestyramine, etc.; 5. In the past 4 weeks, those who have started or changed the dose of the following drugs, such as hepatoprotective drugs, biguanides, metformin, thiazolidinediones, insulin, incretin analogs, fibrates, statins and anti-obesity drugs, etc.; 6. Use of drugs that may have an effect on MAFLD in the past 4 weeks: vitamin E, omega-3 fatty acids, pioglitazone, glucagon-like peptide 1 receptor agonist GLP-1 analogs, dipeptidyl peptidase IV inhibitors, ursodeoxycholic acid, glucose co-transporter 2 (sodium - glucose co-transporter 2, SGLT2) inhibitors, etc.; 7. Patients with difficult blood sugar control, HbA1c greater than 9%; 8. Patients with severe jaundice (serum Tbil level >= 85 µmol/L) or obvious renal insufficiency (serum Cr >= 1.2ULN); 9. Those who have undergone bariatric surgery; 10. Diagnosed or suspected to be combined with malignant tumor; 11. Combined with systemic inflammatory diseases (such as connective tissue diseases); or biliary tract, pancreatic diseases; or chronic or acute infection; or serious diseases such as cardiovascular, pulmonary and hematopoietic systems; or history of myocardial infarction or stroke within 6 months; or mentally ill; 12. HIV-infected persons; 13. Known allergic to rifaximin; 14. There are contraindications to MRI, such as metal implants in the body, claustrophobia or body size exceeding the imaging room capacity, etc.; 15. Patients who are pregnant and lactating or who do not rule out the possibility of pregnancy; 16. Those who have participated in other drug trials within 3 months; 17. Other researchers believe that the participants are not suitable.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes of liver fat content based on MRI measurement;Changes in insulin resistance assessed using a homeostatic model (HOMA-IR); | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes of other indexes of liver function;Other imaging examinations;Changes of liver fat noninvasive scoring system;Improvement of systemic metabolic indexes; | — |
Countries
China
Contacts
Public ContactYin Chuan
Shanghai Changzheng Hospital
Outcome results
None listed