Primary Biliary Cholangitis (PBC)Phase 2NCT03521297
Probiotics in PBC Patients of Poor Response to UDCA
A Phase 2 study testing Probiotic in people with Primary Biliary Cholangitis (PBC), run by Sun Yat-sen University at 1 site in China.
Trial summary
The safety and efficacy of probiotics in primary biliary cholangitis (PBC) patients with poor ursodeoxycholic acid (UDCA) response. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Primary Biliary Cholangitis (PBC)
- What is being tested?
- Probiotic
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 20 Jan 2020to 31 Aug 2021
- Phase
- Phase 2
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- PBC patients (diagnosed with PBC according to 2009 AASLD PBC PRACTICE GUIDANCE), take UDCA more than 12 months and have poor response;
- Age 18-70 years.
Who cannot join
- Any other liver disesases (viral hepatitis, HIV positive, alcohol abuse, hemochromatosis, hepatolenticular degeneration, α1-antitrypsin deficiency and so on);
- Important organ dysfunction such as heart, lung and kidney which affect the life expectancy;
- Have congenital galactosemia, glucose malabsorption syndrome or lactase deficiency.
- Patients allergic to research drugs or excipients;
- Pregnant or lactating women;
- Not signed informed consent;
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- Have antibiotics one month before enrollment;
- Microecological preparations (probiotics, prebiotics, synbiotics, etc.) were used before the enrollment;
- Malignant tumors, nerves and mental disorders;
- Those who participated in other drug clinical trials in the past 3 months.
Trial locations and contacts
1 site in 1 country.
China1 site
Third Affliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510630
Lin B Liang, MD, 86-20-85253165, lamikin@126.com
About this study
Official title: Safety and Efficacy of Probiotics in Primary Biliary Cholangitis (PBC) Patients With Poor Ursodeoxycholic Acid (UDCA) Response
The safety and efficacy of probiotics in primary biliary cholangitis (PBC) patients with poor ursodeoxycholic acid (UDCA) response.
Read the detailed description
PBC patients with poor ursodeoxycholic acid (UDCA) response are selected and randomly assigned into probiotic group and control group. Patients in probiotic group receive probiotic(Micro V Probiotics) combined UDCA for 6 months and then continue to take UDCA alone. Patients in control group continue to take UDCA alone. Biochemical indicators, immunological indicators, liver stiffness, and ultrasound of the two groups of patients were collected. GLOBE and UK-PBC scoring system are used to assesse prognosis.The feces and serum of all patients are collected to observe the differences in fecal microbial polymorphisms in the two groups of patients. Metabolomics are used to study the differences in the bile acids and short chain fatty acid metabolites of the serum and feces of the two groups of PBC patients.
- Conditions
- Primary Biliary Cholangitis (PBC)
- Being tested
- Probiotic, Placebo
- Keywords
- Probiotics, ursodeoxycholic acid (UDCA)
- 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.
ProbioticDrug
Also called Probiotic group
UDCA combined probiotic
PlaceboDietary supplement
UDCA combined placebo
| Study group | Role | What they receive |
|---|---|---|
| Placebo group | Placebo comparator | Placebo (three times per day, one pack each time) and UDCA (13-15mg/kg/day), orally, 6 months Receives: Dietary Supplement: Placebo |
| Probiotics group | Experimental | Probiotics (three times per day, one pack each time) and UDCA(13-15mg/kg/day), orally, 6 months Receives: Drug: Probiotic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biochemical response
Percentage of patients with biochemical response (serum ALP(U/L) or GGT(U/L) decreased by 20% from baseline)
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2018
- Study start20 Jan 2020 (estimated)
- Primary completion31 Jan 2021 (estimated)
- Study completion31 Aug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Biliary Cholangitis (PBC)Studies 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (estimated)
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
- Bingliang Lin, MD, Study director, Third Affliated Hospital of Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03521297
- Sponsor's protocol ID
- PBC-UDCA
- Status last verified
- Jan 2020
- First submitted
- 28 Apr 2018
- Last updated
- 7 Jan 2020
- 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 7 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Probiotics in Primary Biliary Cholangitis (PBC) Patients With Poor Ursodeoxycholic Acid (UDCA) Response
- ClinicalTrials.gov ID
- NCT03521297
- Acronym / sponsor ID
- PBC-UDCA
- Conditions
- Primary Biliary Cholangitis (PBC)
- Keywords
- Probiotics, ursodeoxycholic acid (UDCA)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 20 Jan 2020 (estimated)
- Primary completion
- 31 Jan 2021 (estimated)
- Study completion
- 31 Aug 2021 (estimated)
- First posted
- 11 May 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.
The safety and efficacy of probiotics in primary biliary cholangitis (PBC) patients with poor ursodeoxycholic acid (UDCA) response.
Detailed description
PBC patients with poor ursodeoxycholic acid (UDCA) response are selected and randomly assigned into probiotic group and control group. Patients in probiotic group receive probiotic(Micro V Probiotics) combined UDCA for 6 months and then continue to take UDCA alone. Patients in control group continue to take UDCA alone. Biochemical indicators, immunological indicators, liver stiffness, and ultrasound of the two groups of patients were collected. GLOBE and UK-PBC scoring system are used to assesse prognosis.The feces and serum of all patients are collected to observe the differences in fecal microbial polymorphisms in the two groups of patients. Metabolomics are used to study the differences in the bile acids and short chain fatty acid metabolites of the serum and feces of the two groups of PBC patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo group | Placebo comparator | Dietary Supplement: PlaceboPlacebo (three times per day, one pack each time) and UDCA (13-15mg/kg/day), orally, 6 months |
| Probiotics group | Experimental | Drug: ProbioticProbiotics (three times per day, one pack each time) and UDCA(13-15mg/kg/day), orally, 6 months |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- PBC patients (diagnosed with PBC according to 2009 AASLD PBC PRACTICE GUIDANCE), take UDCA more than 12 months and have poor response;
- Age 18-70 years.
Key exclusion criteria (10 listed)
- Any other liver disesases (viral hepatitis, HIV positive, alcohol abuse, hemochromatosis, hepatolenticular degeneration, α1-antitrypsin deficiency and so on);
- Important organ dysfunction such as heart, lung and kidney which affect the life expectancy;
- Have congenital galactosemia, glucose malabsorption syndrome or lactase deficiency.
- Patients allergic to research drugs or excipients;
- Pregnant or lactating women;
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 |
|---|---|---|
| ProbioticAlso: Probiotic groupUDCA combined probiotic | Drug | Probiotics group |
| PlaceboUDCA combined placebo | Dietary supplement | Placebo group |
Primary outcome
Biochemical response
Time frame: 6 month
Percentage of patients with biochemical response (serum ALP(U/L) or GGT(U/L) decreased by 20% from baseline)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2020.
- 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.
Bingliang Lin, 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?
A Phase 2 study testing Probiotic in people with Primary Biliary Cholangitis (PBC), 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 2 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 7 Jan 2020. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bingliang Lin, MD (13924129928, lamikin@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biochemical response (time frame: 6 month). 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 7 Jan 2020.