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

NCT ID: NCT03590886

Last Updated: 2019-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-08-22

Study Completion Date

2019-02-28

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.

Conditions

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Primary Biliary Cirrhosis

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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total response Group

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

total response Group

Intervention Type OTHER

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

poor response group

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

No interventions assigned to this group

Interventions

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total response Group

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

Intervention Type OTHER

Other Intervention Names

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poor response group

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

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 .
Minimum Eligible Age

30 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sun Yat-sen University

OTHER

Sponsor Role lead

Responsible Party

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Lin Bingliang

professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lin B Liang, MD

Role: STUDY_DIRECTOR

Third Affliated Hospital of Sun Yat-sen University

Locations

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The Third Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

Site Status

Countries

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China

Other Identifiers

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UDCA20181123

Identifier Type: -

Identifier Source: org_study_id