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

Not Applicable
Completed
Conditions
Chronic Hepatitis B
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

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
Primary Outcome Measures
NameTimeMethod
Test the level of HBV infection in chronic hepatitis B patients6 months

Evaluate HBsAg level in IU/mL

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Huashan Hospital Affiliated with Fudan University

🇨🇳

Shanghai, Shanghai, China

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

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