A Retrospective Observational Study on the Effects of Probiotics on HBsAg Clearance

NCT ID: NCT06313255

Last Updated: 2024-05-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-05-09

Study Completion Date

2025-12-31

Brief Summary

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The goal of this retrospective observational study is to find out the effects of probiotics on HBV clearance. The main question it aims to answer is:

Are the probiotics have an effect in promoting HBV clearance? The participants will observe the HBV clearance rate in chronic hepatitis B patients receive probiotics in addition to the routine antiviral therapy.

Researchers will compare the HBV clearance rate in chronic hepatitis B patients receive probiotics and antiviral therapy with those receiving solely antiviral therapy.

Detailed Description

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Conditions

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Chronic Hepatitis B

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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PegIFNα2b

PegIFNα2b

Intervention Type DRUG

The patients receive PegIFNα2b therapy

PegIFNα2b+probiotics

PegIFNα2b+probiotics

Intervention Type DRUG

The patients receive both PegIFNα2b and probiotics therapy

Nucleoside analog

Nucleoside analog

Intervention Type DRUG

The patients receive nucleoside analog therapy

Nucleoside analog+probiotics

Nucleoside analog+probiotics

Intervention Type DRUG

The patients receive both nucleoside analog and probiotics therapy

Interventions

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PegIFNα2b

The patients receive PegIFNα2b therapy

Intervention Type DRUG

PegIFNα2b+probiotics

The patients receive both PegIFNα2b and probiotics therapy

Intervention Type DRUG

Nucleoside analog

The patients receive nucleoside analog therapy

Intervention Type DRUG

Nucleoside analog+probiotics

The patients receive both nucleoside analog and probiotics therapy

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* chronic hepatitis B patients

Exclusion Criteria

* patients with malignancies
* patients with other liver diseases
* pregnancy patients
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Qilu Hospital of Shandong University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Qilu Hospital of Shandong University

Jinan, Shandong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yu-Chen Fan

Role: CONTACT

0086+053182169593

Facility Contacts

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Yu-Chen Fan

Role: primary

0086+053182169596

Other Identifiers

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KYLL-202301-008-1

Identifier Type: -

Identifier Source: org_study_id

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