Probiotics in PBC Patients of Poor Response to UDCA | NCT03521297

Studies
Probiotics in PBC Patients of Poor Response to UDCA

NCT03521297

Sponsor

Sun Yat-sen University

Status

Unknown status

Last Update Posted

Jan 7, 2020Actual

Enrollment

60Estimated

Phase

Phase 2

Conditions

Primary Biliary Cholangitis (PBC)

Interventions

Probiotic
Placebo

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 20, 2020Estimated

Primary Completion Date

Jan 31, 2021Estimated

Completion Date

Aug 31, 2021Estimated

First Submitted Date

Apr 28, 2018

First Submission Date that Met QC Criteria

Apr 28, 2018

First Posted Date

May 11, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 4, 2020

Last Update Posted Date

Jan 7, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Probiotic	Drug	UDCA combined probiotic	Probiotics group	Probiotic group

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Bingliang Lin, MD	Contact	13924129928		lamikin@126.com

Overall Officials

Name	Affiliation	Role
Bingliang Lin, MD	Third Affliated Hospital of Sun Yat-sen University	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Third Affliated Hospital of Sun Yat-sen University		Guangzhou	Guangdong	510630	China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D008105	Liver Cirrhosis, Biliary

Ancestor Terms

ID	Term
D002780	Cholestasis, Intrahepatic
D002779	Cholestasis
D001649	Bile Duct Diseases
D001660	Biliary Tract Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D019936	Probiotics

Ancestor Terms

ID	Term
D019587	Dietary Supplements
D005502	Food
D000066888	Diet, Food, and Nutrition
D010829	Physiological Phenomena

Browse Leaves

Not provided

Browse Branches

Not provided