Clinical trial

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

Name

KYLL-202301-008-1

Description

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.

Trial arms

Trial start

2023-05-09

Estimated PCD

2025-12-31

Trial end

2025-12-31

Status

Recruiting

Treatment

PegIFNα2b

The patients receive PegIFNα2b therapy

Arms:

PegIFNα2b

PegIFNα2b+probiotics

The patients receive both PegIFNα2b and probiotics therapy

Arms:

PegIFNα2b+probiotics

Nucleoside analog

The patients receive nucleoside analog therapy

Arms:

Nucleoside analog

Nucleoside analog+probiotics

The patients receive both nucleoside analog and probiotics therapy

Arms:

Nucleoside analog+probiotics

Size

Primary endpoint

HBsAg clearance

48 months

Eligibility criteria

Inclusion Criteria: * chronic hepatitis B patients Exclusion Criteria: * patients with malignancies * patients with other liver diseases * pregnancy patients

Protocol

{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'CASE_ONLY', 'timePerspective': 'RETROSPECTIVE'}, 'enrollmentInfo': {'count': 40, 'type': 'ESTIMATED'}}

Updated at

2024-05-01

1 organization

3 products

1 indication

Organization

Qilu Hospital of Shandong University

Product

Indication

Product

Product