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

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

Study Overview

• Status: Unknown
• Conditions: Primary Biliary Cholangitis (PBC)
• Intervention / Treatment: Dietary supplement: Placebo; Drug: Probiotic

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 Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Bingliang Lin, MD; Phone Number: 13924129928; Email: lamikin@126.com

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510630
      • Third Affliated Hospital of Sun Yat-sen University
      • Contact: Lin B Liang, MD; Phone Number: 86-20-85253165; Email: lamikin@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Placebo group; Placebo (three times per day, one pack each time) and UDCA (13-15mg/kg/day), orally, 6 months	Dietary supplement: Placebo; UDCA combined placebo
EXPERIMENTAL: Probiotics group; Probiotics (three times per day, one pack each time) and UDCA(13-15mg/kg/day), orally, 6 months	Drug: Probiotic; UDCA combined probiotic; Other Names: Probiotic group

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Sun Yat-sen University
• Investigators: Study Director: Bingliang Lin, MD, Third Affliated Hospital of Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): January 20, 2020
• Primary Completion (ANTICIPATED): January 31, 2021
• Study Completion (ANTICIPATED): August 31, 2021

Study Registration Dates

• First Submitted: April 28, 2018
• First Submitted That Met QC Criteria: April 28, 2018
• First Posted (ACTUAL): May 11, 2018

Study Record Updates

• Last Update Posted (ACTUAL): January 7, 2020
• Last Update Submitted That Met QC Criteria: January 4, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: Probiotics; ursodeoxycholic acid (UDCA)
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Liver Diseases; Fibrosis; Biliary Tract Diseases; Bile Duct Diseases; Cholestasis, Intrahepatic; Cholestasis; Liver Cirrhosis; Cholangitis; Liver Cirrhosis, Biliary
• Other Study ID Numbers: PBC-UDCA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No