Probiotics in PBC Patients of Poor Response to UDCA

Sun Yat-sen University

Status and phase: Unknown; Phase 2

Conditions: Primary Biliary Cholangitis (PBC)

Treatments: Dietary Supplement: Placebo; Drug: Probiotic

Study type: Interventional

Funder types: Other

Identifiers

NCT03521297

PBC-UDCA

Details and patient eligibility

About

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

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups, including a placebo group

Placebo group

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: Placebo

Probiotics group

Experimental group

Description:

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

Treatment:

Drug: Probiotic