Composite Probiotics Stabilize Lipid Metabolism in Chronic Hepatitis B Patients:A Clinical Trial

April 11, 2025 updated by: Wecare Probiotics Co., Ltd.

Probiotic Supplementation With BLa80, BL21, and LRa05 Stabilizes Lipid Metabolism in Chronic Hepatitis B Patients Receiving Tenofovir Alafenamide: A Clinical Trial

The goal of this is to verify the clinical efficacy of compound probiotics in reducing HBV infection levels and regulating intestinal flora in patients with chronic hepatitis B.

The main question it aims to answer is:

• Conventional antiviral therapy combined with a 3-month probiotic intervention was used to evaluate the clinical efficacy of reducing HBV infection levels (HBeAg, HBsAg, and HBV DNA levels) and regulating gut microbiota.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

84

Phase

  • Not Applicable

Contacts and Locations

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

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200000
        • Huashan Hospital Affiliated with Fudan University

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

Yes

Description

Inclusion Criteria:

  1. Meet the hepatitis B clinical diagnostic criteria of the Chronic Hepatitis B Prevention and Treatment Guidelines (2022 edition), excluding patients infected with hepatitis C virus, hepatitis D virus and other hepatitis viruses;
  2. Be aware of the content and purpose of this study, and voluntarily sign the treatment study consent.

Exclusion Criteria:

  1. Patients infected within 3 months;
  2. Received antibiotic treatment within 3 months;
  3. Received probiotic and probiotic therapy within 3 months;
  4. Complicated with hypertension or diabetes;
  5. Obesity or significantly low weight;
  6. Obvious atherosclerosis;
  7. Chronic kidney disease;
  8. Inflammatory bowel disease, irritable bowel syndrome, or a history of gastrointestinal surgery;
  9. Malignant tumors;
  10. Autoimmune diseases;
  11. Mental illnesses such as Parkinson's disease, Alzheimer's disease and stroke;
  12. Pregnant or lactating women;
  13. Patients with cirrhosis or decompensated liver disease;
  14. Subjects cannot participate in the experiment due to their reasons; Those who meet any of the above criteria will not be selected.

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: placebo
Maltodextrin, 1 sachet/day, before meals; Storage: store in a cool, dry place without sun exposure.
Dietary supplement: Probiotic
The intervention lasted for 3 months and 3 visits (at 0 month, 3rd and 6th month respectively).
Experimental: Probiotic group
30 billion CFU/sachet/day, before meals; Compound Probiotics (Bifidobacterium animalis subsp. animalis BLa80、Bifidobacterium longum subsp. longum BL21、Lacticaseibacillus rhamnosus LRa05) Storage: store in a cool, dry place without sun exposure.
Dietary supplement: Probiotic
The intervention lasted for 3 months and 3 visits (at 0 month, 3rd and 6th month respectively).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Test the level of HBV infection in chronic hepatitis B patients
Time Frame: 6 months
Evaluate HBsAg level in IU/mL
6 months

Collaborators and Investigators

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

Sponsor

Wecare Probiotics Co., Ltd.

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)

March 30, 2024

Primary Completion (Actual)

March 10, 2025

Study Completion (Actual)

April 11, 2025

Study Registration Dates

First Submitted

January 11, 2024

First Submitted That Met QC Criteria

January 23, 2024

First Posted (Actual)

January 24, 2024

Study Record Updates

Last Update Posted (Actual)

April 16, 2025

Last Update Submitted That Met QC Criteria

April 11, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WK2023009

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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