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临床试验/NCT07746934
NCT07746934尚未招募不适用

Comparison of Metronidazole- and Tinidazole-Based Bismuth Quadruple Regimens for Helicobacter Pylori Eradication

University of Medicine and Pharmacy at Ho Chi Minh City1 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2026年7月27日最近更新:
适应症
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
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

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

Active Comparator

干预措施: Metronidazole (Drug)

Metronidazole-Based Bismuth Quadruple Therapy

Active Comparator

干预措施: Bismuth Subcitrate (Drug)

Metronidazole-Based Bismuth Quadruple Therapy

Active Comparator

干预措施: esomeprazole 40 mg (Drug)

Tinidazole-Based Bismuth Quadruple Therapy

Experimental

干预措施: Tinidazole 500mg (Drug)

Tinidazole-Based Bismuth Quadruple Therapy

Experimental

干预措施: Bismuth Subcitrate (Drug)

Tinidazole-Based Bismuth Quadruple Therapy

Experimental

干预措施: esomeprazole 40 mg (Drug)

Metronidazole-Based Bismuth Quadruple Therapy

Active Comparator

干预措施: tetracyline (Drug)

Tinidazole-Based Bismuth Quadruple Therapy

Experimental

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

发起方
University of Medicine and Pharmacy at Ho Chi Minh City
申办方类型
Other
责任方
Principal Investigator
主要研究者

Nhu Thi Hanh Vu

Lecturer

University of Medicine and Pharmacy at Ho Chi Minh City

研究点 (1)

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