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

Primary Biliary Cirrhosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03590886
• Other study ID #: UDCA20181123
• Status: Completed
• Start date: August 22, 2018
• Est. completion date: February 28, 2019

Study information

• Verified date: December 2019
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: February 28, 2019
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 70 Years

Eligibility

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 .

Related Conditions & MeSH terms

• Liver Cirrhosis, Biliary
• Primary Biliary Cirrhosis

Intervention

Other:
• total response Group
biochemical response for UDCA treatment more than 1 year according to Paris-I/II standard

Locations

Country	Name	City	State
China	The Third Affiliated Hospital of Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	fecal microbial diversity	Macrogenomic examination of fecal microbial DNA	6 months
Secondary	bile acid metabolites	The examination of bile acid metabolites by ELISA methods	6 months
Secondary	short chain fatty acid metabolites	The examination of short chain fatty metabolites by ELISA methods	6 months