NCT06221605Completed
Composite Probiotics Stabilize Lipid Metabolism in Chronic Hepatitis B Patients:A Clinical Trial
Probiotic Supplementation With BLa80, BL21, and LRa05 Stabilizes Lipid Metabolism in Chronic Hepatitis B Patients Receiving Tenofovir Alafenamide: A Clinical Trial
Source: ClinicalTrials.gov · Last updated 16 Apr 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 84 (actual)
- First submitted
- 11 Jan 2024
- Start date
- 30 Mar 2024
- Primary completion date
- 10 Mar 2025
- Lead sponsor
- Wecare Probiotics Co., Ltd.
- Diseases
- Hepatitis B
- NCT number
- NCT06221605
What you commit to
- Study type: Interventional
- Participants enrolled: 84
- From 30 Mar 2024 to the primary completion date, 10 Mar 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Received antibiotic treatment within 3 months;
- Received probiotic and probiotic therapy within 3 months;
Other illness
- Patients infected within 3 months;
- Complicated with hypertension or diabetes;
- 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;
- Patients with cirrhosis or decompensated liver disease;
Other
- Obesity or significantly low weight;
- Obvious atherosclerosis;
- Pregnant or lactating women;
- Subjects cannot participate in the experiment due to their reasons; Those who meet any of the above criteria will not be selected.
Who the study is looking for
- 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.
Age in the registry: 18 years to 80 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Huashan Hospital Affiliated with Fudan University Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.