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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03590886

Enrollment

Registered

2018-07-18

Start date

2018-08-22

Completion date

2019-02-28

Last updated

2019-12-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary Biliary Cirrhosis

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.

Interventions

OTHERtotal response Group

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

Study design

Observational model

OTHER

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

30 Years to 70 Years

Healthy volunteers

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 .

Design outcomes

Primary

Measure	Time frame	Description
fecal microbial diversity	6 months	Macrogenomic examination of fecal microbial DNA

Secondary

Measure	Time frame	Description
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

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026