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Clinical Trial Summary

The safety and efficacy of probiotics in primary biliary cholangitis (PBC) patients with poor ursodeoxycholic acid (UDCA) response.


Clinical Trial Description

PBC patients with poor ursodeoxycholic acid (UDCA) response are selected and randomly assigned into probiotic group and control group. Patients in probiotic group receive probiotic(Micro V Probiotics) combined UDCA for 6 months and then continue to take UDCA alone. Patients in control group continue to take UDCA alone. Biochemical indicators, immunological indicators, liver stiffness, and ultrasound of the two groups of patients were collected. GLOBE and UK-PBC scoring system are used to assesse prognosis.The feces and serum of all patients are collected to observe the differences in fecal microbial polymorphisms in the two groups of patients. Metabolomics are used to study the differences in the bile acids and short chain fatty acid metabolites of the serum and feces of the two groups of PBC patients. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03521297
Study type Interventional
Source Sun Yat-sen University
Contact Bingliang Lin, MD
Phone 13924129928
Email lamikin@126.com
Status Not yet recruiting
Phase Phase 2
Start date January 20, 2020
Completion date August 31, 2021

See also
  Status Clinical Trial Phase
Recruiting NCT03188146 - Performance of Scoring Systems in Chinese Patients With Primary Biliary Cholangitis (PBC) on Ursodeoxycholic Acid
Recruiting NCT05896124 - CS0159 in Chinese Patients With PBC (Primary Biliary Cholangitis) Phase 2
Recruiting NCT06016842 - A Long-Term Study of Elafibranor in Adult Participants With Primary Biliary Cholangitis Phase 3
Completed NCT04047160 - Safety, Tolerability of OP-724 in Patients With Primary Biliary Cholangitis (Phase I) Phase 1
Completed NCT03124108 - Study to Evaluate the Efficacy and Safety of Elafibranor in Patients With Primary Biliary Cholangitis (PBC) and Inadequate Response to Ursodeoxycholic Acid Phase 2