NCT07012785尚未招募不适用
Efficacy Analysis of Saccharomyces Boulardii Combined With Minocycline in Treatment-naïve Patients With Helicobacter Pylori Infection
Zhongda Hospital1 个研究点 分布在 1 个国家目标入组 208 人开始时间: 2025年6月最近更新:
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 208
- 试验地点
- 1
- 主要终点
- H. Pylori eradication rate
研究概览
简要总结
To assess the efficacy and safety of Saccharomyces boulardii combined with triple therapy containing minocycline in the initial eradication of Helicobacter pylori (H. pylori) infection
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18-70 years, regardless of gender;
- •Positive 13C/14C urea breath test result;
- •No previous history of H. pylori eradication treatment;
- •Agreement to participate in this study and signing of the informed consent form.
排除标准
- •History of ≥ 1 instance of failed H. pylori eradication;
- •Use of antibiotics (including antibacterial traditional Chinese medicines), nonsteroidal anti-inflammatory drugs (NSAIDS), bismuth agents, H2 receptor antagonists (H2RAs), proton-pump inhibitors (PPIs), and potassium-competitive acid blockers (P-CAB) within 4 weeks before treatment;
- •Plans to conceive, pregnancy, or breastfeeding;
- •Severe liver, kidney, or cardiovascular diseases; malignancies; and alcoholism;
- •Allergies to the drugs used in this study or a history of penicillin allergy;
- •The inability to correctly express one's symptoms and wishes, such as inability due to mental illness or severe neurosis.
研究组 & 干预措施
Control Group
Active Comparator
干预措施: Bismuth quadruple therapy (Drug)
Experimental group
Experimental
干预措施: Saccharomyces boulardii (Drug)
结局指标
主要结局
H. Pylori eradication rate
时间窗: 7 days
次要结局
未报告次要终点
研究者
Chen Lu
Director
Zhongda Hospital
研究点 (1)
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