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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Clinical Study About Gut Microbes and Metabolic Group in Different PBC Patients for UDCA Response

Conditions
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Primary Biliary Cirrhosis

Intervention / Treatment
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* Other: total response Group


Participation Criteria
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Eligibility Criteria
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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: Viral liver disease; alcoholic liver disease; fatty liver; drug-associated liver damage; infectious disease; obesity; gastrointestinal diseases; combined with other autoimmune diseases; cardiac and pulmonary dysfunction; renal dysfunction, malignant tumor,; neurological and psychiatric abnormalities; nearly 2 months to take antibiotics and probiotics; nearly 3 months participate in other drug clinical trials .

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| total response Group<br>The PBC patients show biochemical response for UDCA treatment more than 1 year according to Paris-I/II standard | Other: total response Group<br>* biochemical response for UDCA treatment more than 1 year according to Paris-I/II standard<br>* Other names: poor response group;|
| poor response group<br>The PBC patients show poor biochemical response for UDCA treatment more than 1 year according to Paris-I/II standard | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| fecal microbial diversity | Macrogenomic examination of fecal microbial DNA | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| bile acid metabolites | The examination of bile acid metabolites by ELISA methods | 6 months | 
| short chain fatty acid metabolites | The examination of short chain fatty metabolites by ELISA methods | 6 months |