Probiotics in PBC Patients of Poor Response to UDCA

NCT ID: NCT03521297

Last Updated: 2020-01-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-20
• Study Completion Date: 2021-08-31

Brief Summary

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.

Conditions

Primary Biliary Cholangitis (PBC)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Placebo group

Placebo (three times per day, one pack each time) and UDCA (13-15mg/kg/day), orally, 6 months

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

UDCA combined placebo

Probiotics group

Probiotics (three times per day, one pack each time) and UDCA(13-15mg/kg/day), orally, 6 months

Group Type: EXPERIMENTAL

Probiotic

Intervention Type: DRUG

UDCA combined probiotic

Interventions

Probiotic

UDCA combined probiotic

Intervention Type: DRUG

Placebo

UDCA combined placebo

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Probiotic group

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Lin Bingliang

professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Bingliang Lin, MD

Role: STUDY_DIRECTOR

Third Affliated Hospital of Sun Yat-sen University

Locations

Third Affliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

Countries

China

Central Contacts

Bingliang Lin, MD

Role: CONTACT

lamikin@126.com

13924129928

Facility Contacts

Lin B Liang, MD

Role: primary

lamikin@126.com

86-20-85253165

Other Identifiers

PBC-UDCA

Identifier Type: -

Identifier Source: org_study_id