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

NCT ID: NCT06221605

Last Updated: 2025-04-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-30
• Study Completion Date: 2025-04-11

Brief Summary

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.

Conditions

Chronic Hepatitis B

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Probiotic

Intervention Type: DIETARY_SUPPLEMENT

The intervention lasted for 3 months and 3 visits (at 0 month, 3rd and 6th month respectively).

placebo

Maltodextrin, 1 sachet/day, before meals; Storage: store in a cool, dry place without sun exposure.

Group Type: PLACEBO_COMPARATOR

Probiotic

Intervention Type: DIETARY_SUPPLEMENT

The intervention lasted for 3 months and 3 visits (at 0 month, 3rd and 6th month respectively).

Interventions

Probiotic

The intervention lasted for 3 months and 3 visits (at 0 month, 3rd and 6th month respectively).

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Wecare Probiotics Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Huashan Hospital Affiliated with Fudan University

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

WK2023009

Identifier Type: -

Identifier Source: org_study_id