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

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.

Study Overview

• Status: Completed
• Conditions: Primary Biliary Cirrhosis
• Intervention / Treatment: Other: total response Group

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 Type: Observational
• Enrollment (Actual): 60

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510630
      • The Third Affiliated Hospital of Sun Yat-sen University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Primary biliary cholangitis patients

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
total response Group; The PBC patients show biochemical response for UDCA treatment more than 1 year according to Paris-I/II standard	Other: total response Group; biochemical response for UDCA treatment more than 1 year according to Paris-I/II standard; Other Names: poor response group
poor response group; The PBC patients show poor biochemical response for UDCA treatment more than 1 year according to Paris-I/II standard

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
bile acid metabolites	The examination of bile acid metabolites by ELISA methods	6 months
short chain fatty acid metabolites	The examination of short chain fatty metabolites by ELISA methods	6 months

Collaborators and Investigators

• Sponsor: Sun Yat-sen University
• Investigators: Study Director: Lin B Liang, MD, Third Affliated Hospital of Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 22, 2018
• Primary Completion (ACTUAL): December 31, 2018
• Study Completion (ACTUAL): February 28, 2019

Study Registration Dates

• First Submitted: June 27, 2018
• First Submitted That Met QC Criteria: July 17, 2018
• First Posted (ACTUAL): July 18, 2018

Study Record Updates

• Last Update Posted (ACTUAL): December 24, 2019
• Last Update Submitted That Met QC Criteria: December 23, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Liver Diseases; Fibrosis; Biliary Tract Diseases; Bile Duct Diseases; Cholestasis, Intrahepatic; Cholestasis; Liver Cirrhosis; Liver Cirrhosis, Biliary
• Other Study ID Numbers: UDCA20181123

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No