Probiotics in PBC Patients of Poor Response to UDCA

• Status: Not yet recruiting
• Trial end date: 2021-08-31
• Target enrollment: 0
• Participant gender: All

Summary

The safety and efficacy of probiotics in primary biliary cholangitis (PBC) patients with poor ursodeoxycholic acid (UDCA) response.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sun Yat-sen University
• Treatments: Ursodeoxycholic Acid

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, α1-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.