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A single-center, randomized, single-blind clinical study to evaluate the efficacy and safety of rifaximin in the treatment of primary biliary cholangitis

A single-center, randomized, single-blind clinical study to evaluate the efficacy and safety of rifaximin in the treatment of primary biliary cholangitis

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100046346
Enrollment
Unknown
Registered
2021-05-14
Start date
2021-06-01
Completion date
Unknown
Last updated
2021-12-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

primary biliary cholangitis

Interventions

Ursodeoxycholic acid group:Ursodeoxycholic acid
Rifaximin group :UDCA and rifaximin

Sponsors

Xiangya Hospital of Central South University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 75 years; 2. Patients with newly-onset primary biliary cholangitis; 3. Volunteer to participate in this study and sign a written informed consent.

Exclusion criteria

Exclusion criteria: 1. Have taken antibiotics in the past 2 months; 2. Take intestinal microecological preparations in the past 2 months; 3. Have a history of drinking in the past 3 months; 4. History of other liver diseases such as genetic metabolic diseases, hepatitis, liver cancer; 5. Infectious diarrhea, chronic diarrhea, irritable bowel syndrome, inflammatory diseases and other intestinal diseases; 6. Pregnant and lactating women; 7. Patients with serious mental illness, drug abuse, alcohol abuse, etc. who cannot cooperate with the study; 8. Those who have participated in any other clinical research within 1 month before entering the screening (Visit 1); 9. The investigator judges that any other diseases or conditions are not suitable for patients participating in this study.

Design outcomes

Primary

MeasureTime frame
liver function;Kidney function;Coagulation;Immunization full set;ANA Spectrum;Blood routine;

Secondary

MeasureTime frame
Anti-neutrophil antibody;

Countries

China

Contacts

Public ContactLiu Xiaowei

Xiangya Hospital

liuxw@csu.edu.cn+86 13548762632

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026