Composite Probiotics Stabilize Lipid Metabolism in Chronic Hepatitis B Patients: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.

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Key information

Conditions

Chronic Hepatitis B Blood-Borne Infections Chronic Disease Communicable Diseases DNA Virus Infections Digestive System Diseases Disease Attributes Hepadnaviridae Infections Hepatitis Hepatitis B Hepatitis B, Chronic Hepatitis, Chronic Hepatitis, Viral, Human Infections Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Virus Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Huashan Hospital Affiliated with Fudan University

Shanghai, Shanghai Municipality, 200000, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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;
Be aware of the content and purpose of this study, and voluntarily sign the treatment study consent.

Exclusion criteria

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

Treatment and study plan

Probiotic

Dietary Supplement

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

Primary outcomes

Test the level of HBV infection in chronic hepatitis B patients

Time frame: 6 months

Evaluate HBsAg level in IU/mL

Sponsors and collaborators

Lead sponsor

Wecare Probiotics Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start: 2024
Primary completion: 2025
Study completion: 2025
First posted: Jan 24, 2024
Registry last updated: Apr 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed