NCT06607562已完成不适用
The Improvement Effects of Weizmannia Coagulans BC99 on Liver Function and Gut Microbiota of Long-Term Alcohol Drinkers: A Randomized Double-Blind Clinical Trial
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Change from baseline in serum ALT, AST, γ-GT, and total bilirubin (TBil) levels
研究概览
简要总结
To evaluate the effectiveness and safety of using probiotics to protect the liver function of long-term alcohol consumers
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)
入排标准
- 年龄范围
- 19 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •A history of long-term heavy alcohol consumption, equivalent to ethanol intake ≥40g/day for over 1 year. The conversion formula is: ethanol (g) = volume of ethanol-containing beverage (mL) × ethanol content (%) × 0.8 (specific gravity of ethanol);
- •Body Mass Index (BMI) between 18kg/m² and 25kg/m²;
- •Voluntarily signed a written informed consent form, agreeing to participate in this study;
- •Agreed to comply with the study protocol and restrictions;
- •Subjects (including male participants) have no plans for conception from 14 days prior to screening until 6 months after the end of the trial and voluntarily agree to use effective contraception.
排除标准
- •Patients with various types of viral hepatitis, autoimmune liver disease, drug-induced liver damage, vascular liver disease, genetic metabolic liver disease, or primary liver cancer;
- •Individuals who have recently consumed substances with similar functions to the tested product, potentially affecting the study results;
- •Patients with severe allergies or immune deficiencies;
- •Pregnant, breastfeeding, or women with plans for pregnancy;
- •Individuals with severe diseases of vital organs such as cardiovascular, pulmonary, hepatic, renal conditions, or those with diabetes, severe thyroid disorders, metabolic diseases, malignant tumors, or severe immune system disorders;
- •Individuals who have used antibiotics within the past two weeks;
- •Participants who did not comply with the required consumption of the tested product or missed follow-ups, making it impossible to evaluate the effectiveness;
- •Other participants deemed unsuitable by the researchers.
研究组 & 干预措施
Placebo
Placebo Comparator
Maltodextrin one Sachet/Day Storage: Store in cool and dry place without sun exposure.
干预措施: Placebo group (Dietary Supplement)
Probiotics group
Experimental
10B CFU/Sachet/Day Weizmannia coagulans BC99 Storage: Store in cool and dry place without sun exposure.
干预措施: Probiotic group (Dietary Supplement)
结局指标
主要结局
Change from baseline in serum ALT, AST, γ-GT, and total bilirubin (TBil) levels
时间窗: 60 days
Change from baseline to Day 60 in serum alanine aminotransferase (ALT), aspartate aminotransferase (AST), gamma-glutamyl transferase (γ-GT), and total bilirubin (TBil), measured using an automated biochemical analyzer.
次要结局
未报告次要终点
研究者
研究点 (1)
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