Probiotic Supplementation With BLa80, BL21, and LRa05 Stabilizes Lipid Metabolism in Chronic Hepatitis B Patients Receiving Tenofovir Alafenamide: A Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Test the level of HBV infection in chronic hepatitis B patients
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
placebo
Maltodextrin, 1 sachet/day, before meals; Storage: store in a cool, dry place without sun exposure.
干预措施: Probiotic (Dietary Supplement)
Probiotic group
30 billion 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.
干预措施: Probiotic (Dietary Supplement)
结局指标
主要结局
Test the level of HBV infection in chronic hepatitis B patients
时间窗: 6 months
Evaluate HBsAg level in IU/mL
次要结局
未报告次要终点