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

Completed

• Conditions: Primary Biliary Cirrhosis
• Interventions: Other: total response Group

• Registration Number: NCT03590886
• Lead Sponsor: Sun Yat-sen University

Brief Summary

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

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 Timeline

• Study First Submitted: 2018-06-27
• Study First Submitted QC: 2018-07-17
• Study First Posted: 2018-07-18
• Study Start: 2018-08-22
• Primary Completion: 2018-12-31
• Study Completion: 2019-02-28
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-23
• Last Update Posted: 2019-12-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 .

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
total response Group	total response Group	The PBC patients show biochemical response for UDCA treatment more than 1 year according to Paris-I/II standard

Primary Outcome Measures

Name	Time	Method
fecal microbial diversity	6 months	Macrogenomic examination of fecal microbial DNA

Secondary Outcome Measures

Name	Time	Method
bile acid metabolites	6 months	The examination of bile acid metabolites by ELISA methods
short chain fatty acid metabolites	6 months	The examination of short chain fatty metabolites by ELISA methods

Trial Locations

Locations (1)

The Third Affiliated Hospital of Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China