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

Recruiting

• Conditions: Chronic Hepatitis B
• Interventions: Drug: PegIFNα2b; Drug: PegIFNα2b+probiotics; Drug: Nucleoside analog; Drug: Nucleoside analog+probiotics

• Registration Number: NCT06313255
• Lead Sponsor: Qilu Hospital of Shandong University

Brief Summary

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

Not available

Study Timeline

• Study Start: 2023-05-09
• Status Verified: 2024-03
• Study First Submitted: 2024-03-10
• Study First Submitted QC: 2024-03-10
• Study First Posted: 2024-03-15
• Last Update Submitted: 2024-04-30
• Last Update Posted: 2024-05-01
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• chronic hepatitis B patients

Exclusion Criteria

• patients with malignancies
• patients with other liver diseases
• pregnancy patients

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
PegIFNα2b	PegIFNα2b	-
PegIFNα2b+probiotics	PegIFNα2b+probiotics	-
Nucleoside analog	Nucleoside analog	-
Nucleoside analog+probiotics	Nucleoside analog+probiotics	-

Primary Outcome Measures

Name	Time	Method
HBsAg clearance	48 months

Trial Locations

Locations (1)

Qilu Hospital of Shandong University; 🇨🇳 Jinan, Shandong, China