Probiotics in PBC Patients of Poor Response to UDCA

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

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03521297

Enrollment

Registered

2018-05-11

Start date

2020-01-20

Completion date

2021-08-31

Last updated

2020-01-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary Biliary Cholangitis (PBC)

Keywords

Probiotics, ursodeoxycholic acid (UDCA)

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.

Interventions

DRUGProbiotic

UDCA combined probiotic

DIETARY_SUPPLEMENTPlacebo

UDCA combined placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Investigator)

Masking description

single(Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

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.

Design outcomes

Primary

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

Countries

China

Contacts

Primary ContactBingliang Lin, MD

lamikin@126.com13924129928

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026