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

Wecare Probiotics Co., Ltd.84 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Chronic Hepatitis B

Interventions

ProbioticDIETARY_SUPPLEMENT

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Huashan Hospital Affiliated with Fudan University

Shanghai, Shanghai Municipality, China

Outcomes

Primary Outcomes

Test the level of HBV infection in chronic hepatitis B patients

Evaluate HBsAg level in IU/mL

Time frame: 6 months

Data from ClinicalTrials.gov

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