Primary biliary cholangitis (PBC)
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Aged >= 18 years and < 75 years. 2. Patients with primary PBC who have been clearly diagnosed. 3. Take UDCA continuously for no more than 3 months. 4. Voluntarily participate in the study and sign a written informed consent.
Exclusion criteria
Exclusion criteria: 1. Antibiotics have been taken in the last 2 months. 2. In recent 2 months, I have taken intestinal microecological preparations. 3. History of drinking within the last 3 months. 4. History of inherited metabolic diseases, viral hepatitis, cirrhosis, liver cancer and other liver diseases. 5. Infectious diarrhea, chronic diarrhea, irritable bowel syndrome, inflammatory diseases and other intestinal diseases. 6. Pregnant and lactating patients. 7. Patients with severe mental illness, drug abuse, alcohol abuse, etc., who could not cooperate with the study were included. 8. Participated in any other clinical investigator within 1 month prior to screening (visit). 9. At the time of screening (visit), newly diagnosed patients have been taking UDCA for more than one month. 10. Patients with any other diseases or conditions that the investigator determined were not eligible for participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| quality of life scale;UDCA biochemical response rate;alkaline phosphatase (ALP);?-glutamyltransferase(GGT); | — |
Secondary
| Measure | Time frame |
|---|---|
| human type III procollagen peptide;serum type IV collagen;serum laminin;serum hyaluronidase; | — |
Countries
China
Contacts
Longhua Hospital Shanghai University of Traditional Chinese Medicine