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

Not Applicable

Completed

• Conditions: Chronic Hepatitis B
• Interventions: Dietary Supplement: Probiotic

• Registration Number: NCT06221605
• Lead Sponsor: Wecare Probiotics Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-01-11
• Study First Submitted QC: 2024-01-23
• Study First Posted: 2024-01-24
• Study Start: 2024-03-30
• Primary Completion: 2025-03-10
• Status Verified: 2025-04
• Study Completion: 2025-04-11
• Last Update Submitted: 2025-04-11
• Last Update Posted: 2025-04-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 84

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	Probiotic	Maltodextrin, 1 sachet/day, before meals; Storage: store in a cool, dry place without sun exposure.
Probiotic group	Probiotic	15B 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.

Primary Outcome Measures

Name	Time	Method
Test the level of HBV infection in chronic hepatitis B patients	6 months	Evaluate HBsAg level in IU/mL

Trial Locations

Locations (1)

Huashan Hospital Affiliated with Fudan University; 🇨🇳 Shanghai, Shanghai, China