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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03521297 |
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Date of registration:
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28/04/2018 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Probiotics in PBC Patients of Poor Response to UDCA
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Scientific title:
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Safety and Efficacy of Probiotics in Primary Biliary Cholangitis (PBC) Patients With Poor Ursodeoxycholic Acid (UDCA) Response |
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Date of first enrolment:
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January 20, 2020 |
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Target sample size:
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60 |
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Recruitment status: |
Not yet recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT03521297 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Investigator).
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Phase:
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Phase 2
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Countries of recruitment
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China
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Contacts
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Name:
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Bingliang Lin, MD |
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Address:
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Telephone:
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13924129928 |
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Email:
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lamikin@126.com |
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Affiliation:
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Name:
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Bingliang Lin, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Third Affliated Hospital of Sun Yat-sen University |
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Name:
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Lin B Liang, MD |
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Address:
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Telephone:
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86-20-85253165 |
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Email:
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lamikin@126.com |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. PBC patients (diagnosed with PBC according to 2009 AASLD PBC PRACTICE GUIDANCE), take
UDCA more than 12 months and have poor response;
2. Age 18-70 years.
Exclusion Criteria:
1. Any other liver disesases (viral hepatitis, HIV positive, alcohol abuse,
hemochromatosis, hepatolenticular degeneration, a1-antitrypsin deficiency and so on);
2. Important organ dysfunction such as heart, lung and kidney which affect the life
expectancy;
3. Have congenital galactosemia, glucose malabsorption syndrome or lactase deficiency.
4. Patients allergic to research drugs or excipients;
5. Pregnant or lactating women;
6. Not signed informed consent;
7. Have antibiotics one month before enrollment;
8. Microecological preparations (probiotics, prebiotics, synbiotics, etc.) were used
before the enrollment;
9. Malignant tumors, nerves and mental disorders;
10. Those who participated in other drug clinical trials in the past 3 months.
Age minimum:
18 Years
Age maximum:
70 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Primary Biliary Cholangitis (PBC)
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Intervention(s)
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Drug: Probiotic
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Dietary Supplement: Placebo
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Primary Outcome(s)
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Biochemical response
[Time Frame: 6 month]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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