- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03590886
Gut Microbes and Metabolic Group in Different PBC Patients for UDCA Response
December 23, 2019 updated by: Lin Bingliang, Sun Yat-sen University
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
Intervention / Treatment
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
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Guangdong
-
Guangzhou, Guangdong, China, 510630
- The Third Affiliated Hospital of Sun Yat-sen University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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:
- 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 .
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
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
|
biochemical response for UDCA treatment more than 1 year according to Paris-I/II standard
Other Names:
|
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
Time Frame: 6 months
|
Macrogenomic examination of fecal microbial DNA
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
bile acid metabolites
Time Frame: 6 months
|
The examination of bile acid metabolites by ELISA methods
|
6 months
|
short chain fatty acid metabolites
Time Frame: 6 months
|
The examination of short chain fatty metabolites by ELISA methods
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Lin B Liang, MD, Third Affliated Hospital of Sun Yat-sen University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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