NCT03521297

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 28, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 11, 2018

Completed
1.7 years until next milestone

Study Start

First participant enrolled

January 20, 2020

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2021

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2021

Completed
Last Updated

January 7, 2020

Status Verified

January 1, 2020

Enrollment Period

1 year

First QC Date

April 28, 2018

Last Update Submit

January 4, 2020

Conditions

Primary Biliary Cholangitis (PBC)

Keywords

Probioticsursodeoxycholic acid (UDCA)

Outcome Measures

Primary Outcomes (1)

  • Biochemical response

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

    6 month

Study Arms (2)

Placebo group

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo

Probiotics group

EXPERIMENTAL

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

Drug: Probiotic

Interventions

ProbioticDRUG

UDCA combined probiotic

Also known as: Probiotic group
Probiotics group
PlaceboDIETARY_SUPPLEMENT

UDCA combined placebo

Placebo group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Third Affliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510630, China

Location

MeSH Terms

Conditions

Liver Cirrhosis, Biliary

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Cholestasis, IntrahepaticCholestasisBile Duct DiseasesBiliary Tract DiseasesDigestive System DiseasesLiver DiseasesLiver CirrhosisFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dietary SupplementsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Bingliang Lin, MD

    Third Affliated Hospital of Sun Yat-sen University

    STUDY DIRECTOR

Central Study Contacts

Bingliang Lin, MD

CONTACT

13924129928lamikin@126.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
single(Investigator)
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

April 28, 2018

First Posted

May 11, 2018

Study Start

January 20, 2020

Primary Completion

January 31, 2021

Study Completion

August 31, 2021

Last Updated

January 7, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)