Probiotics in PBC Patients of Poor Response to UDCA

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03521297
• Date of registration: 28/04/2018
• Prospective Registration: Yes
• Primary sponsor: Sun Yat-sen University
• Public title: Probiotics in PBC Patients of Poor Response to UDCA
• Scientific title: Safety and Efficacy of Probiotics in Primary Biliary Cholangitis (PBC) Patients With Poor Ursodeoxycholic Acid (UDCA) Response
• Date of first enrolment: January 20, 2020
• Target sample size: 60
• Recruitment status: Not yet recruiting
• URL: https://clinicaltrials.gov/show/NCT03521297
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Investigator).
• Phase: Phase 2

Countries of recruitment

China

Contacts

• Name: Lin B Liang, MD

• Name: Bingliang Lin, MD

• Name: Bingliang Lin, MD
• Affiliation: Third Affliated Hospital of Sun Yat-sen University

Key inclusion & exclusion criteria

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

Health Condition(s) or Problem(s) studied

Primary Biliary Cholangitis (PBC)

Intervention(s)

Drug: Probiotic

Dietary Supplement: Placebo

Primary Outcome(s)

Biochemical response [Time Frame: 6 month]

Secondary ID(s)

PBC-UDCA

Source(s) of Monetary Support

Please refer to primary and secondary sponsors