Comparison of Metronidazole- and Tinidazole-Based Bismuth Quadruple Regimens for Helicobacter Pylori Eradication
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Helicobacter pylori Eradication Rate
研究概览
简要总结
This randomized, open-label clinical trial will compare two bismuth-containing quadruple therapies for the first-line treatment of Helicobacter pylori infection. Adults aged 18 years or older with confirmed H. pylori infection who have not previously received eradication treatment will be randomly assigned in a 1:1 ratio to receive either a metronidazole-based regimen or a tinidazole-based regimen for 14 days. Both regimens will also include esomeprazole, tetracycline, and bismuth subcitrate.
The main purpose of the study is to determine whether the tinidazole-based regimen is not inferior to the metronidazole-based regimen in achieving successful H. pylori eradication. Eradication will be assessed after treatment using a carbon-13 urea breath test or an endoscopic urease test. The study will also compare adverse effects and treatment tolerability between the two groups. The results may help clinicians select the more appropriate nitroimidazole for bismuth quadruple therapy in routine clinical practice.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18 years or older.
- •Confirmed Helicobacter pylori infection
- •Willing and able to provide written informed consent.
排除标准
- •Pregnancy or breastfeeding.
- •Gastrointestinal malignancy.
- •Previous H. pylori eradication therapy.
- •Liver cirrhosis.
- •Stage IV or V chronic kidney disease.
- •Previous gastric surgery.
- •Known allergy to any study medication.
- •Use of antibiotics within the previous 4 weeks.
研究组 & 干预措施
Metronidazole-Based Bismuth Quadruple Therapy
干预措施: Metronidazole (Drug)
Metronidazole-Based Bismuth Quadruple Therapy
干预措施: Bismuth Subcitrate (Drug)
Metronidazole-Based Bismuth Quadruple Therapy
干预措施: esomeprazole 40 mg (Drug)
Tinidazole-Based Bismuth Quadruple Therapy
干预措施: Tinidazole 500mg (Drug)
Tinidazole-Based Bismuth Quadruple Therapy
干预措施: Bismuth Subcitrate (Drug)
Tinidazole-Based Bismuth Quadruple Therapy
干预措施: esomeprazole 40 mg (Drug)
Metronidazole-Based Bismuth Quadruple Therapy
干预措施: tetracyline (Drug)
Tinidazole-Based Bismuth Quadruple Therapy
干预措施: tetracyline (Drug)
结局指标
主要结局
Helicobacter pylori Eradication Rate
时间窗: At least 4 weeks after completion of the 14-day eradication treatment
次要结局
- Side effects(During the 14-day eradication treatment)
研究者
Nhu Thi Hanh Vu
Lecturer
University of Medicine and Pharmacy at Ho Chi Minh City
