A Randomized Controlled Study: Concomitant Versus Hybrid Therapy in the Treatment of Helicobacter Pylori Infection
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 159
- 试验地点
- 1
- 主要终点
- Helicobacter pylori status one month after treatment.
研究概览
简要总结
The aim of the study is to compare the effectiveness of two therapeutic protocols in the treatment of Helicobacter pylori infection.
The hypothesis of our research is that the two therapeutic options (hybrid and concomitant therapy) will be equally successful in the treatment of Helicobacter pylori infection. In other words, in both therapeutic groups we expect successful treatment of Helicobacter pylori infection in or more than 90 % of patients.
In other studies, both therapeutic options have the same efficacy in treating H. pylori infection. On the other had there are no studies available in Croatia to compare the effectiveness of these therapeutic options so far, which is the main objective of our research. The secondary goals of our study will be: the existence of differences in the occurrence of possible side effects, as well as the compliance between patients in both therapeutic options. It is also our aim to compare the quality of life of patients with Helicobacter pylori infection before and after treatment, via a questionnaire that is common for this purpose.
The study is expected to include a total of 120 patients (60 patients in each therapy group), and the planned duration is 12 months.
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
- •Helicobacter pylori infection (documented by: positive antigen stool test, or positive urease rapid test obtained during upper endoscopy, or Helicobacter pylori in histological finding, or positive C-urea breath test; according to recent Maastricht V guidelines;
- •written informed consent
排除标准
- •age under 18
- •previously treatment of Helicobacter pylori infection
- •malignancy of stomach or other site
- •history of taking proton pump inhibitors, H2 antagonist, bismuth or antibiotics (amoxicillin, metronidazole, clarithromycin) in previous month
- •significant underlying disease (renal failure, psychiatric disorders)
- •history of allergic reactions to any medications used in study
- •refuse to participate in study
- •breastfeeding and pregnancy
- •quitting the study
研究组 & 干预措施
Concomitant therapy
Amoxicillin ('Amoksicilin') 1 g bid, metronidazole ('Medazol')500 mg bid, clarithromycin ('Makcin')500 mg bid and esomeprazole ('Emanera')40 mg bid for 14 days.
干预措施: Concomitant therapy (Drug)
Hybrid therapy
Amoxicillin ('Amoksicilin') 1 g bid and esomeprazole ('Emanera') 40 mg bid for 14 days, with metronidazole ('Medazol')500 bid and clarithromycin ('Makcin') 500 mg bid for the last 7 days.
干预措施: Hybrid therapy (Drug)
结局指标
主要结局
Helicobacter pylori status one month after treatment.
时间窗: One month after finishing with therapy.
Helicobacter pylori status (positive or negative), will be measured by stool test, one month after finishing with therapy.
次要结局
- Compliance of patients in both therapy groups in treatment of Helicobacter pylori infection.(One month after finishing with therapy.)
- Adverse effects of therapy in both groups in treatment of Helicobacter pylori infection.(One month after finishing with therapy.)
研究者
Antonio Mestrovic
Sponsor-Investigator
University of Split, School of Medicine