Primary Biliary CirrhosisNCT03590886
Gut Microbes and Metabolic Group in Different PBC Patients for UDCA Response
An observational study of Primary Biliary Cirrhosis, run by Sun Yat-sen University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Primary Biliary Cirrhosis
- What is being tested?
- total response Group
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 22 Aug 2018to 28 Feb 2019
- How long will I take part?
- 5 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Primary biliary cholangitis patients
Who may be able to join
- 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.
Who cannot join
- Viral liver disease;
- alcoholic liver disease;
- fatty liver;
- drug-associated liver damage;
- infectious disease;
- obesity;
Show all 13Show fewer
- 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 .
Trial locations and contacts
1 site in 1 country.
China1 site
The Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510630
About this study
Official title: 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.
Read the 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.
- Conditions
- Primary Biliary Cirrhosis
- Being tested
- total response Group
- Medical subject headings
- Liver Cirrhosis, Biliary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
total response GroupOther
Also called poor response group
biochemical response for UDCA treatment more than 1 year according to Paris-I/II standard
| Study group | Role | What they receive |
|---|---|---|
| total response Group | The PBC patients show biochemical response for UDCA treatment more than 1 year according to Paris-I/II standard Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
fecal microbial diversity
Macrogenomic examination of fecal microbial DNA
Measured: 6 months
Secondary outcomes (2)
bile acid metabolites
The examination of bile acid metabolites by ELISA methods
Measured: 6 months
short chain fatty acid metabolites
The examination of short chain fatty metabolites by ELISA methods
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2018
- Study start22 Aug 2018
- Primary completion31 Dec 2018
- Study completion28 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Biliary CirrhosisStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (actual)
- Target duration
- 5 Months
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lin Bingliang, Sun Yat-sen University
- Investigators
- Lin B Liang, MD, Study director, Third Affliated Hospital of Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03590886
- Sponsor's protocol ID
- UDCA20181123
- Status last verified
- Dec 2019
- First submitted
- 27 Jun 2018
- Last updated
- 24 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study About Gut Microbes and Metabolic Group in Different PBC Patients for UDCA Response
- ClinicalTrials.gov ID
- NCT03590886
- Acronym / sponsor ID
- UDCA20181123
- Conditions
- Primary Biliary Cirrhosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 22 Aug 2018 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 28 Feb 2019 (actual)
- First posted
- 18 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 5 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| total response Group | – | Other: total response GroupThe PBC patients show biochemical response for UDCA treatment more than 1 year according to Paris-I/II standard |
| poor response group | – | –The PBC patients show poor biochemical response for UDCA treatment more than 1 year according to Paris-I/II standard |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Primary biliary cholangitis patients
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (13 listed)
- Viral liver disease;
- alcoholic liver disease;
- fatty liver;
- drug-associated liver damage;
- infectious disease;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| total response GroupAlso: poor response groupbiochemical response for UDCA treatment more than 1 year according to Paris-I/II standard | Other | total response Group |
Primary outcome
fecal microbial diversity
Time frame: 6 months
Macrogenomic examination of fecal microbial DNA
2 secondary outcomes
bile acid metabolites
Time frame: 6 months
short chain fatty acid metabolites
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lin B Liang, MD study director
Third Affliated Hospital of Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Primary Biliary Cirrhosis, run by Sun Yat-sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
fecal microbial diversity (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2019.