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Probiotics in PBC Patients of Poor Response to UDCA

Primary Purpose

Primary Biliary Cholangitis (PBC)

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Probiotic
Placebo
Sponsored by
Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Biliary Cholangitis (PBC) focused on measuring Probiotics, ursodeoxycholic acid (UDCA)

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Third Affliated Hospital of Sun Yat-sen University

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo group

Probiotics group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
April 28, 2018
Last Updated
January 4, 2020
Sponsor
Sun Yat-sen University
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1. Study Identification

Unique Protocol Identification Number
NCT03521297
Brief Title
Probiotics in PBC Patients of Poor Response to UDCA
Official Title
Safety and Efficacy of Probiotics in Primary Biliary Cholangitis (PBC) Patients With Poor Ursodeoxycholic Acid (UDCA) Response
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 20, 2020 (Anticipated)
Primary Completion Date
January 31, 2021 (Anticipated)
Study Completion Date
August 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Biliary Cholangitis (PBC)
Keywords
Probiotics, ursodeoxycholic acid (UDCA)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Investigator
Masking Description
single(Investigator)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
Placebo (three times per day, one pack each time) and UDCA (13-15mg/kg/day), orally, 6 months
Arm Title
Probiotics group
Arm Type
Experimental
Arm Description
Probiotics (three times per day, one pack each time) and UDCA(13-15mg/kg/day), orally, 6 months
Intervention Type
Drug
Intervention Name(s)
Probiotic
Other Intervention Name(s)
Probiotic group
Intervention Description
UDCA combined probiotic
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
UDCA combined placebo
Primary Outcome Measure Information:
Title
Biochemical response
Description
Percentage of patients with biochemical response (serum ALP(U/L) or GGT(U/L) decreased by 20% from baseline)
Time Frame
6 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bingliang Lin, MD
Phone
13924129928
Email
lamikin@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bingliang Lin, MD
Organizational Affiliation
Third Affliated Hospital of Sun Yat-sen University
Official's Role
Study Director
Facility Information:
Facility Name
Third Affliated Hospital of Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510630
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lin B Liang, MD
Phone
86-20-85253165
Email
lamikin@126.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Probiotics in PBC Patients of Poor Response to UDCA

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