An observational study in Primary Biliary Cirrhosis, sponsored by Sun Yat-sen University. Completed at 1 site in China. Open to participants aged 30 Years to 70 Years. Per ClinicalTrials.gov, last updated 2019-12-24.
Sponsored by Sun Yat-sen University · Observational
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.
208 studies on the registry are indexed under Liver Cirrhosis, Biliary; 44 are open to participants now.
This study's enrollment of 60 is below the median of 300 across 49 observational studies indexed under Liver Cirrhosis, Biliary.
Browse Liver Cirrhosis, Biliary studies →Sun Yat-sen University is the lead sponsor of 1,644 studies on the registry; 602 are open to participants now.
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Primary biliary cholangitis patients
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:
The PBC patients show biochemical response for UDCA treatment more than 1 year according to Paris-I/II standard
Other: total response Group
The PBC patients show poor biochemical response for UDCA treatment more than 1 year according to Paris-I/II standard
biochemical response for UDCA treatment more than 1 year according to Paris-I/II standard
Also known as: poor response group
fecal microbial diversity
Macrogenomic examination of fecal microbial DNA
Time frame: 6 months
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
Plan to share: No
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This study is completed, as verified in Dec 2019. You cannot join it, but the record below documents what was studied.
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Sun Yat-sen University