Probiotics in PBC Patients of Poor Response to UDCA

Sponsor

Sun Yat-sen University (Other)

Overall Status

Unknown status

CT.gov ID

NCT03521297

Collaborator

(none)

Enrollment

Location

Arms

19.4

Anticipated Duration (Months)

3.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Primary Biliary Cholangitis (PBC)	Drug: Probiotic Dietary Supplement: Placebo	Phase 2

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 Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Investigator)

Masking Description:

single(Investigator)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Jan 20, 2020

Anticipated Primary Completion Date :

Jan 31, 2021

Anticipated Study Completion Date :

Aug 31, 2021

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Third Affliated Hospital of Sun Yat-sen University	Guangzhou	Guangdong	China	510630

Sponsors and Collaborators

Sun Yat-sen University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Lin Bingliang, professor, Sun Yat-sen University

ClinicalTrials.gov Identifier:

NCT03521297

Other Study ID Numbers:

PBC-UDCA

First Posted:

May 11, 2018

Last Update Posted:

Jan 7, 2020

Last Verified:

Jan 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Lin Bingliang, professor, Sun Yat-sen University

Probiotics

ursodeoxycholic acid (UDCA)

Additional relevant MeSH terms:

Cholangitis

Liver Cirrhosis, Biliary

Study Results

No Results Posted as of Jan 7, 2020