Probiotics in PBC Patients of Poor Response to UDCA

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

Detailed Description
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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.

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

Conditions
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Primary Biliary Cholangitis (PBC)

Intervention / Treatment
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* Drug: Probiotic
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: PBC patients (diagnosed with PBC according to 2009 AASLD PBC PRACTICE GUIDANCE), take UDCA more than 12 months and have poor response; Age 18-70 years. Exclusion Criteria: Any other liver disesases (viral hepatitis, HIV positive, alcohol abuse, hemochromatosis, hepatolenticular degeneration, α1-antitrypsin deficiency and so on); Important organ dysfunction such as heart, lung and kidney which affect the life expectancy; Have congenital galactosemia, glucose malabsorption syndrome or lactase deficiency. Patients allergic to research drugs or excipients; Pregnant or lactating women; Not signed informed consent; Have antibiotics one month before enrollment; Microecological preparations (probiotics, prebiotics, synbiotics, etc.) were used before the enrollment; Malignant tumors, nerves and mental disorders; Those who participated in other drug clinical trials in the past 3 months.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo group<br>Placebo (three times per day, one pack each time) and UDCA (13-15mg/kg/day), orally, 6 months | Dietary Supplement: Placebo<br>* UDCA combined placebo<br>|
| Experimental: Probiotics group<br>Probiotics (three times per day, one pack each time) and UDCA(13-15mg/kg/day), orally, 6 months | Drug: Probiotic<br>* UDCA combined probiotic<br>* Other names: Probiotic group;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biochemical response | Percentage of patients with biochemical response (serum ALP(U/L) or GGT(U/L) decreased by 20% from baseline) | 6 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Probiotics, ursodeoxycholic acid (UDCA)