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NCT06313255 Clinical Trial

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

Chronic Hepatitis B Clinical Trial

Official title:
A Retrospective Observational Study on the Effects of Probiotics on HBsAg Clearance

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06313255
Other study ID # KYLL-202301-008-1
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date May 9, 2023
Est. completion date December 31, 2025

Study information
Verified date March 2024
Source Qilu Hospital of Shandong University
Contact Yu-Chen Fan
Phone 0086+053182169593
Email fanyuchen@sdu.edu.cn
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 40
Est. completion date December 31, 2025
Est. primary completion date December 31, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - chronic hepatitis B patients Exclusion Criteria: - patients with malignancies - patients with other liver diseases - pregnancy patients

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• PegIFNa2b
The patients receive PegIFNa2b therapy
• PegIFNa2b+probiotics
The patients receive both PegIFNa2b and probiotics therapy
• Nucleoside analog
The patients receive nucleoside analog therapy
• Nucleoside analog+probiotics
The patients receive both nucleoside analog and probiotics therapy

Locations
Country Name City State
China Qilu Hospital of Shandong University Jinan Shandong

Sponsors (1)
Lead Sponsor Collaborator
Qilu Hospital of Shandong University

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary HBsAg clearance 48 months
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