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

March 10, 2024 updated by: Qilu Hospital of Shandong University

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

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shandong
      • Jinan, Shandong, China, 250012
        • Recruiting
        • Qilu Hospital Of Shandong University
        • Contact:
        • Principal Investigator:
          • Yu-Chen Fan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

The study population is patients with chronic hepatitis B who are receiving antiviral therapy with or without prebiotics.

Description

Inclusion Criteria:

  • chronic hepatitis B patients

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
PegIFNα2b
Drug: PegIFNα2b
The patients receive PegIFNα2b therapy
PegIFNα2b+prebiotics
Drug: PegIFNα2b+prebiotics
The patients receive both PegIFNα2b and prebiotics therapy
Nucleoside analog
Drug: Nucleoside analog
The patients receive nucleoside analog therapy
Nucleoside analog+prebiotics
Drug: Nucleoside analog+prebiotics
The patients receive both nucleoside analog and prebiotics therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
HBsAg clearance
Time Frame: 48 months
48 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Qilu Hospital of Shandong University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 9, 2023

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

March 10, 2024

First Submitted That Met QC Criteria

March 10, 2024

First Posted (Actual)

March 15, 2024

Study Record Updates

Last Update Posted (Actual)

March 15, 2024

Last Update Submitted That Met QC Criteria

March 10, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KYLL-202301-008-1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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