primary biliary cholangitis
Conditions
Interventions
Group 1:Combine probiotics and prebiotics in the first three months
Group 2:Combine probiotics and prebiotics from 4th to 6th month
Sponsors
Shulan (Hang zhou) Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: Patients aged between 18 and 70 years who were diagnosed with PBC were enrolled, both at the beginning and after treatment. PBC can be diagnosed by meeting two of the following three criteria: (1) increase of biochemical indicators reflecting cholestasis, such as ALP; (2) positive AMA or AMA-M2; (3) the serum AMA/ AMA-M2 was negative, but the liver biopsy pathology was consistent with PBC
Exclusion criteria
Exclusion criteria: 1. Nursing women; 2. Pregnant women; 3. Used antibiotics and probiotics/yuan within 2 months before screening; 4. Complicated with AIH, SLE, sjogren's syndrome and other autoimmune diseases; 5. Active hepatitis a, c, d (where available), e and/or HIV infection; 6. If there are signs and symptoms of hepatocellular carcinoma and AFP 50 ng/mL is screened, imaging examination is required; 7. Chronic liver disease not caused by PBC (e.g., hemochromatosis, fatty liver, cholangitis); 8. Currently, there is evidence of child-pugh grade C decompensated liver disease, or moderate to severe ascites, grade iii-iv hepatic encephalopathy; 9. Abnormal hematological and biochemical indicators, including: Albumin 2.3 ULN (unless anticoagulant regimen is stable); Total bilirubin >3 ULN 10. Patients who are allergic to probiotics/biotics or their metabolites or formula excipients and who receive long-term treatment that is not compatible with probiotics/biotics; 11. The existence of any other clinical condition or previous treatment will make the patient unfit for this study or unable to comply with the medication requirements of this study; 12. Patients who are participating in other trials or who have been treated with the study drug for 12 weeks prior to screening; 13. The researchers suggest that current alcohol or drug abuse may affect compliance; 14. Inability or unwillingness to provide informed consent or to comply with research requirements; 15. In addition to the above exclusion criteria, patients who meet any contraindications in the experimental drug specification.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Liver and kidney function;Complete Blood Count;blood lipid;metabolites in faeces; | — |
Countries
China
Contacts
Public ContactHainv Gao
Shulan (Hang zhou) Hospital
Outcome results
None listed