Gut Microbes and Metabolic Group in Different PBC Patients for UDCA Response

Sun Yat-sen University60 enrolled

Overview

To compare intestinal flora diversity in different PBC patients with UDCA responses, and further study the differences of bile acid metabolism and short chain fatty acid metabolism in feces and serum of two groups of PBC patients.

The PBC patients have been enrolled in the study for UDCA treatment more than 1 year, who is divided into the UDCA total response Group and the other poor response group according to Paris-I/II standard .The feces of two groups of patients were collected and the differences of microbial polymorphism of fecal microorganism in two groups were observed. The metabolic differences of bile acids and short chain fatty acids in serum and feces of two groups of PBC patients were studied by means of metabolic proteomics.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Primary Biliary Cirrhosis

Interventions

total response GroupOTHER

biochemical response for UDCA treatment more than 1 year according to Paris-I/II standard

Eligibility

Sex: ALLMin age: 30 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1.Confirmed diagnostic criteria about PBC, and orally UDCA treatment for more than a year; 2.30-70 years old; 3.Currently only UDCA therapy, not glucocorticoids and immunosuppressor treatment. Exclusion Criteria: 1. Viral liver disease; 2. alcoholic liver disease; 3. fatty liver; 4. drug-associated liver damage; 5. infectious disease; 6. obesity; 7. gastrointestinal diseases; 8. combined with other autoimmune diseases; 9. cardiac and pulmonary dysfunction; 10. renal dysfunction, malignant tumor,; 11. neurological and psychiatric abnormalities; 12. nearly 2 months to take antibiotics and probiotics; 13. nearly 3 months participate in other drug clinical trials .

Locations (1)

The Third Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

Outcomes

Primary Outcomes

fecal microbial diversity

Macrogenomic examination of fecal microbial DNA

Time frame: 6 months

Secondary Outcomes

bile acid metabolites

The examination of bile acid metabolites by ELISA methods

Time frame: 6 months

short chain fatty acid metabolites

The examination of short chain fatty metabolites by ELISA methods

Time frame: 6 months

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.