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

Sun Yat-sen University

Status: Completed

Conditions: Primary Biliary Cirrhosis

Treatments: Other: total response Group

Study type: Observational

Funder types: Other

Identifiers

NCT03590886

UDCA20181123

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 30 to 70 years old

Volunteers: No 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 .

Trial design

60 participants in 2 patient groups

total response Group

Description:

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

Treatment:

Other: total response Group

poor response group

Description:

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