Probiotics in PBC Patients of Poor Response to UDCA

Primary Biliary Cholangitis (PBC) Clinical Trial

Official title:

Safety and Efficacy of Probiotics in Primary Biliary Cholangitis (PBC) Patients With Poor Ursodeoxycholic Acid (UDCA) Response

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03521297
• Other study ID #: PBC-UDCA
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: January 20, 2020
• Est. completion date: August 31, 2021

Study information

• Verified date: January 2020
• Source: Sun Yat-sen University
• Contact: Bingliang Lin, MD
• Phone: 13924129928
• Email: lamikin[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: August 31, 2021
• Est. primary completion date: January 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cholangitis
• Liver Cirrhosis, Biliary
• Primary Biliary Cholangitis (PBC)

Intervention

Drug:
• Probiotic
UDCA combined probiotic

Dietary Supplement:
• Placebo
UDCA combined placebo

Locations

Country	Name	City	State
China	Third Affliated Hospital of Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Biochemical response	Percentage of patients with biochemical response (serum ALP(U/L) or GGT(U/L) decreased by 20% from baseline)	6 month