A Multi-center Study for Individual Treatment of Helicobacter Pylori Infection
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 3,000
- 主要终点
- Eradication rates
研究概览
简要总结
Since the discovery of Helicobacter pylori (H. pylori), many studies have been carried out with the goal of improving H. pylori eradication and therapies have changed from single-antibiotic treatments to the current multi-antibiotic treatments. However, the eradication rate of H. pylori is still less than 80%. The reasons for this low eradication rate are likely to be multi-factorial, including the reduced activity of antimicrobial drugs, poor patient compliance or micro-environment in stomach. In this study, to obtain the higher eradication of H. pylori and discover the different mechanism between the current infection and refractory infection of H. pylori, it is necessary to perform a prevalence survey for eradication of H. pylori based on the results from isolation of H. pylori strains, antibiotic susceptibility testing, CYP2C19 gene polymorphism, drug resistance gene sequencing and 16SrRNA sequencing.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18~70 years old, male or female, untreated patients.
- •Symptoms of abdominal pain, bloating, acid reflux, belching, nausea, vomiting, heartburn, chest pain, vomiting, melena, etc.
- •Unused antibiotics, bismuth, H2 receptor antagonists or PPI by nearly 4 weeks
- •13C-labelled urea breath test positive.
- •5.Agreed to Helicobacter pylori culture and sensitivity testing taken by endoscopy gastric biopsy specimens,and the result of culture was positive.
- •6.Agreed to Helicobacter pylori eradication therapy and cooperate with the eradication efficacy follow-up survey.
排除标准
- •Severe heart, liver, kidney dysfunction.
- •Pregnant or lactating women.
- •Complications of bleeding, perforation, pyloric obstruction, cancer.
- •Esophageal,gastrointestinal surgery history.
- •Patients can not properly express their complaints,such as psychosis, severe neurosis.
- •Taking NSIAD or alcohol abusers.
- •Allergic to penicillin or either drugs of the 6 antibiotic tested by susceptibility testing.
结局指标
主要结局
Eradication rates
时间窗: Three months
To investigate the eradication rates of H.Pylori after individual quadruple therapy based on antibiotic susceptibility testing, CYP2C19 gene polymorphism, drug resistance gene sequencing and 16SrRNA sequencing.
Mutation site of drug resistance gene
时间窗: Three months
To discover the difference of mutation site in drug resistance gene between successful patients and refractory patients by second-generation sequencing.
The distribution and proportion of microflora in stomach
时间窗: Three months
To discover the distribution and proportion of microflora in stomach between successful patients and refractory patients of H. Pylori infection by 16SrRNA sequencing.
次要结局
未报告次要终点
研究者
Youming Li
Director of the Department of Gastroenterology
First Affiliated Hospital of Zhejiang University