A Relevance Study Between the Result of Clinical Drug Intervention and Next-generation Sequencing Technology Focused on Refractory Helicobacter Pylori Infection
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 1,845
- 试验地点
- 4
- 主要终点
- The proportion of mix infection of H pylori in a total of 40 patients in two groups
研究概览
简要总结
Approximately 50% of people in the world are infected with H. pylori, and its eradication rate fail to exceed 80% and even fails into an unacceptable range.Various risk factors for infection include lower socioeconomic status, younger age, and geographic location.In the present study, investigators aimed to perform a prevalence survey about risk factors for H. pylori infection.To obtain the higher eradication of H. pylori and find out the relevance between the diverse infection and clinical drug focused on refractory H. pylori infection.
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 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.
- •Agreed to Helicobacter pylori culture and sensitivity testing taken by endoscopy gastric biopsy specimens,and the result of culture was positive.
- •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.
研究组 & 干预措施
Successful treatment
干预措施: The eradication times of the patients (Device)
Successful treatment
干预措施: The result of 13C-urea breath test after treatment (Device)
Refractory infection of H.pylori
干预措施: The eradication times of the patients (Device)
Refractory infection of H.pylori
干预措施: The result of 13C-urea breath test after treatment (Device)
结局指标
主要结局
The proportion of mix infection of H pylori in a total of 40 patients in two groups
时间窗: 2.5 year
Analyzed the next-generation sequencing data,obtain the proportion of mixed infection with different H. pylori strain in refractory cases.
The eradication rate of H. pylori reach to 95%
时间窗: 1.5 year
The eradication rate of untreated cases reach to 98%.The eradication rate of refractory cases reach to 90%.
Obtain the first resistant pattern to antibiotics in shenzhen area
时间窗: 1.5 year
The results of antibiotic susceptibility testing were analyzed in this study.More than 1800 patients were participated,these patients were representative in five hospitals of shenzhen area.
次要结局
- The incidence of adverse effects in the eradicate treatment(2.5 year)
- The difference between microbial genes of different patients(3 year)
- The relevance between mixed infection, microflora structure and risk factors(3 year)
研究者
TaoLYU
Deputy Director of the Department of Gastroenterology
The University of Hong Kong-Shenzhen Hospital