A Randomized, Open-label Study on Helicobacter Pylori Eradication With Standard Triple Regimen Plus Acetazolamide
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- H. pylori eradication rate
研究概览
简要总结
Helicobacter pylori infection is associated with several gastric diseases, including gastritis, peptic and duodenal ulcers, gastric carcinoma and MALToma. In 1994, the WHO classified the organism as a type 1 carcinogen. In order to eradicate H. pylori, at least two antibiotics and a proton pump inhibitor are used as a standard therapy regimen. Emerging antibiotic resistance to metronidazole or clarithromycin, however, has made successful treatment of infection progressively more difficult, with the success rate of standard triple therapy now at 70%, well below the 80% required for treatment of infectious diseases. Therefore, new treatment regimen is required for successful H. pylori eradication.
On the other hands, many in vitro studies revealed that bacterial carbonic anhydrase in H. pylori has an important role for surviving of H. pylori in the stomach. It was demonstrated that mutation of carbonic anhydrase affected survival of H. pylori. The investigators therefore expected that administration of carbonic anhydrase inhibitor (acetazolamide) with standard H. pylori eradication regimen would increase the eradication rate. Here, the investigators aim to evaluate the efficacy of standard triple regimen plus acetazolamide for H. pylori eradication.
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
- 19 Years 至 70 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age, between 19 and 70
- •H. pylori infected patients
排除标准
- •Previous history of H. pylori eradication
- •Previous history of gastrectomy
- •Administration of PPI, H2 blocker, antibiotics, or bismuth within 1 month prior to enrollment
- •Allergy to sulfonamide
- •Electrolyte imbalance
- •Adrenal insufficiency
- •Pregnancy or breast milk feeding
- •Active infection
- •Severe hepatic dysfunction
- •Severe renal dysfunction
- •Severe bone marrow dysfunction
- •Significant neurologic or psychologic disease
研究组 & 干预措施
Arm1
Treatment group
干预措施: Acetazolamide group (Drug)
Arm2
Control group
干预措施: Standard regimen group (Drug)
结局指标
主要结局
H. pylori eradication rate
时间窗: 1 month from the eradication therapy
H. pylori eradication rate will be assessed by urea breath test after eradication therapy.
次要结局
未报告次要终点
