Autoimmune hepatitis
Conditions
Interventions
Intervention group:Oral synbiotics and liver protection drugs
Control group:liver protection drugs
Sponsors
The Second Hospital of Shanxi Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Probable or definite diagnosis of autoimmune hepatitis according to the Autoimmune Hepatitis Diagnosis and Treatment Guidelines (2021) criteria; 2. Male or female, 18 to 75 years old; 3. Is capable of understanding and signing the informed consent document; 4. No history of using Hormone or Immunosuppressive agents; 5. Not belong to acute or severe AIH.
Exclusion criteria
Exclusion criteria: 1. Patients with liver damage caused by other reasons (such as viral, drug, alcoholic and non-alcoholic fatty liver disease, etc); 2. Those with acute severe complications, those with critical illnesses such as liver cirrhosis, decompensated hepatic encephalopathy, and liver failure; 3. Has history of alcohol intake>25 g/day within the past six months; 4. Pregnant or lactating women; 5. Has unstable and uncontrollable hypertension (> 180/110 mmHg); 6. Severe anemia, leukopenia, or thrombocytopenia; 7. Patients with severe heart, brain, lung, kidney, immune and other system diseases; 8. Has any form of current substance abuse, psychiatric disorder or a condition that, in the opinion of the Investigator, may invalidate communication with the Investigator; 9. Have an active infection (eg, acute hepatitis E, cytomegalovirus, or Epstein-Barr virus) requiring systemic therapy with antibiotic, antiviral, or antifungal treatment, or has had any febrile illness within 7 days prior to Day-1; 10. Has received other investigational agents within 90 days prior to the first screening visit.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| T Lymphocyte subgroup analysis; | — |
Secondary
| Measure | Time frame |
|---|---|
| Cytokine detection;Liver biochemical indexes;C-reactive protein;Erythrocyte Sedimentation Rate;Liver ultrasound; | — |
Countries
China
Contacts
Public ContactZhihua Deng
The Second Hospital of Shanxi Medical University
Outcome results
None listed