Probiotics in PBC Patients of Poor Response to UDCA

Phase 2

• Conditions: Primary Biliary Cholangitis (PBC)
• Interventions: Dietary Supplement: Placebo; Drug: Probiotic

• Registration Number: NCT03521297
• Lead Sponsor: Sun Yat-sen University

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.

Study Timeline

• Study First Submitted: 2018-04-28
• Study First Submitted QC: 2018-04-28
• Study First Posted: 2018-05-11
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-04
• Last Update Posted: 2020-01-07
• Study Start: 2020-01-20
• Primary Completion: 2021-01-31
• Study Completion: 2021-08-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo group	Placebo	Placebo (three times per day, one pack each time) and UDCA (13-15mg/kg/day), orally, 6 months
Probiotics group	Probiotic	Probiotics (three times per day, one pack each time) and UDCA(13-15mg/kg/day), orally, 6 months

Primary Outcome Measures

Name	Time	Method
Biochemical response	6 month	Percentage of patients with biochemical response (serum ALP(U/L) or GGT(U/L) decreased by 20% from baseline)

Trial Locations

Locations (1)

Third Affliated Hospital of Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China