A Retrospective Observational Study on the Effects of Probiotics on HBsAg Clearance
1 other identifier
observational
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started May 2023
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 9, 2023
CompletedFirst Submitted
Initial submission to the registry
March 10, 2024
CompletedFirst Posted
Study publicly available on registry
March 15, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2025
CompletedMay 1, 2024
March 1, 2024
2.6 years
March 10, 2024
April 30, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
HBsAg clearance
48 months
Study Arms (4)
PegIFNα2b
PegIFNα2b+probiotics
Nucleoside analog
Nucleoside analog+probiotics
Interventions
The patients receive both PegIFNα2b and probiotics therapy
The patients receive both nucleoside analog and probiotics therapy
Eligibility Criteria
The study population is patients with chronic hepatitis B who are receiving antiviral therapy with or without probiotics.
You may qualify if:
- chronic hepatitis B patients
You may not qualify if:
- patients with malignancies
- patients with other liver diseases
- pregnancy patients
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Qilu Hospital of Shandong University
Jinan, Shandong, 250012, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 10, 2024
First Posted
March 15, 2024
Study Start
May 9, 2023
Primary Completion
December 31, 2025
Study Completion
December 31, 2025
Last Updated
May 1, 2024
Record last verified: 2024-03