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

NCT03590886 | Completed

• 1 other identifier: UDCA20181123
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Primary Biliary Cirrhosis

Outcome Measures

Primary Outcomes (1)

• fecal microbial diversity

  Macrogenomic examination of fecal microbial DNA

  6 months

Secondary Outcomes (2)

• bile acid metabolites

  6 months

• short chain fatty acid metabolites

  6 months

Study Arms (2)

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

poor response group

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

Interventions

total response Group OTHER

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

Also known as: poor response group

total response Group

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Primary biliary cholangitis patients

You may qualify if:

• 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.

You may not qualify if:

• Viral liver disease;
• alcoholic liver disease;
• fatty liver;
• drug-associated liver damage;
• infectious disease;
• obesity;
• gastrointestinal diseases;
• combined with other autoimmune diseases;
• cardiac and pulmonary dysfunction;
• renal dysfunction, malignant tumor,;
• neurological and psychiatric abnormalities;
• nearly 2 months to take antibiotics and probiotics;
• nearly 3 months participate in other drug clinical trials .

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

The Third Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510630, China

Location

MeSH Terms

Conditions

Liver Cirrhosis, Biliary

Condition Hierarchy (Ancestors)

Cholestasis, Intrahepatic; Cholestasis; Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases; Liver Diseases; Liver Cirrhosis; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Lin B Liang, MD

  Third Affliated Hospital of Sun Yat-sen University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Target Duration: 5 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: June 27, 2018
• First Posted: July 18, 2018
• Study Start: August 22, 2018
• Primary Completion: December 31, 2018
• Study Completion: February 28, 2019
• Last Updated: December 24, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)