Clinical Evaluation of a 14day Modified Bismuth Quadruple Therapy for the Eradication of H. Pylori in a High Clarithromycin and Metronidazole Resistance Area
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 150
- 主要终点
- Effectiveness to eradicate helicobacter pylori with modified bismuth-containing treatment
研究概览
简要总结
The goal of this clinical trial is to learn if a modified bismuth-containing therapy for the treatment of helicobacter pylori infection works to treat chronic helicobacter pylori related gastritis in adults treated either for first time or after a previous failure of another helicbacter erdication therapy. It will also learn about the safety and compliance of the modified bismuth containing therapy for helicobacter pylori.
The main questions it aims to answer are:
Does the modified bismuth-containing therapy for helicobacter pylori maintains a high eradication profile? What medical problems do participants have when taking the bismuth containing therapy? Researchers will present the eradication percentage of the modified bismuth containing therapy for helicobacter pylori in a difficult to treat population with a high profile of resistance to antibiotics for the treatment of helicobacter pylori separately for first time treated patients or patients with previous failures of other therapies.
Participants will:
Take the modified bismuth containing therapy which consists of four different medications (esomeprazole, amoxicillin, metronidazole, bismuth subcitrate) taken for 14 days in selected timepoints.
Visit the clinic at the end of therapy for checkups and at 6 to 8 weeks after the end of therapy for final evaluation of completed eradication.
Keep a diary of their symptoms and the number of medications taken.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Patients of 18 years or older with dyspepsia or iron deficiency anaemia, referring for upper GI endoscopy and found to be infected with Helicobacter pylori (positive rapid urease test or histology), naïve or experienced to H. pylori eradication treatment, will be invited to participate in the study.
排除标准
- •Exclusion criteria are: age below 18 years, presence of severe co-morbidities (i.e. liver cirrhosis, renal failure, haematological, neurological, psychiatric, severe cardiovascular or pulmonary disease), previous gastric surgery, gastric malignancies, Zollinger-Elisson syndrome, known allergy or other contraindications to the study medications, previous H. pylori bismuth containing therapies, use of antibiotics , bismuth salts , NSAIDS or aspirin in the preceding month, use of PPI in the preceding two weeks and not willing to participate in the study. Pregnant or lactating women will also be excluded.
研究组 & 干预措施
Helicobacter pylori infected
This arm will include patients who have to receive eradication therapy for the first time as first line or experienced patients who have to receive eradication as rescue therapy for third or further line, respectively.
干预措施: Modified bismuth-containing eradication treatment (Drug)
结局指标
主要结局
Effectiveness to eradicate helicobacter pylori with modified bismuth-containing treatment
时间窗: From enrollment to the end of treatment and assessment of eradication results at 8-10 weeks
Participants achieved helicobacter pylori eradication if they perform negative at 13C-urea breath test (13C-UBT) 6-8 weeks after completion of modified bismuth-containing treatment
次要结局
- Secondary outcomes are to assess patient's compliance and adverse events(From enrollment to the end of evaluation at 8 weeks)
研究者
ILIAS XIROUCHAKIS
Dr Ilias Xirouchakis MD, FEBGH
Athens Medical Center