Construction and Application of the Treatment of Refractory Helicobacter Pylori Infection Based on the High-throughput Sequencing Technologies
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 4,428
- 试验地点
- 1
- 主要终点
- The microflora structure of a total of 240 patients in the first successful eradication group and the refractory infection of H. pylori group
研究概览
简要总结
Recently studies showed that the eradication rate of H. pylori fail to exceed 80% and even falls into an unacceptable range. A major cause of treatment failure is associated with antibiotic resistance and poor patient compliance. However, the refractory infection of H. pylori is still existing, although patients have good compliance and receive standardized treatment. This phenomenon is likely attributed to the different ratio of sensitive and resistance in H. pylori, the difference of Amoxicillin resistance between in vivo and in vitro, the difference between phenotype and genotype or the influence of micro-environment in the stomach. In order to solve the refractory infection of H. pylori, investigators performed a muti-center study together with other 14 institutions. In this study, investigators will select the patients with refractory infection of H. pylori after two standardized treatment from patients with first eradication therapy of H. pylori infection. Then, investigators will perform a high-throughput sequencing for patients in groups. Finally, investigators will compare the differences between the patients with first successful eradication and patients with refractory infection of H. pylori, such as drug resistance gene mutation, phenotype and genotype, the mechanisms of Amoxicillin resistance and micro-environment in stomach.
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, the first eradication therapy of H. pylori infection patients.
- •Symptoms of abdominal pain, bloating, acid efflux, belching, nausea, vomiting, heartburn, chest pain, vomiting, melena, etc.
- •Unused antibiotics, bismuth, H2 receptor antagonists or PPIs 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 nonsteroidal antiinflammatory drugs (NSAIDs) or alcohol abusers.
- •Allergic to penicillin or either drugs of the 6 antibiotic tested by susceptibility testing.
研究组 & 干预措施
H pylori culture negative group
The patients who have the negative result of H pylori culture were classified into H pylori culture negative group.
干预措施: The result of H pylori culture based on gram staining and enzyme activity testing (Device)
The first successful eradication group
The patients with first eradication therapy of H. pylori infection have the first successful treatment based on the standardized treatment including antibiotics selection from antibiotic susceptibility testing and proton pump inhibitors （PPIs) dose selection from CYP2C19 gene sequencing.
干预措施: The result of H pylori culture based on gram staining and enzyme activity testing (Device)
The first successful eradication group
The patients with first eradication therapy of H. pylori infection have the first successful treatment based on the standardized treatment including antibiotics selection from antibiotic susceptibility testing and proton pump inhibitors （PPIs) dose selection from CYP2C19 gene sequencing.
干预措施: The result of 13C-urea breath test after treatment based on the selection of clarithromycin, levofloxacin, metronidazole, amoxicillin，tetracycline，furazolidone and the dose of esomeprazole (Device)
The first successful eradication group
The patients with first eradication therapy of H. pylori infection have the first successful treatment based on the standardized treatment including antibiotics selection from antibiotic susceptibility testing and proton pump inhibitors （PPIs) dose selection from CYP2C19 gene sequencing.
干预措施: The result of Amoxicillin resistance in vitro based on antibiotic susceptibility testing (Device)
The refractory infection of H. pylori group
The patients with first eradication therapy of H. pylori infection have the two failure treatment based on the standardized treatment including antibiotics selection from antibiotic susceptibility testing and PPIs dose selection from CYP2C19 gene sequencing.
干预措施: The result of H pylori culture based on gram staining and enzyme activity testing (Device)
The refractory infection of H. pylori group
The patients with first eradication therapy of H. pylori infection have the two failure treatment based on the standardized treatment including antibiotics selection from antibiotic susceptibility testing and PPIs dose selection from CYP2C19 gene sequencing.
干预措施: The result of 13C-urea breath test after treatment based on the selection of clarithromycin, levofloxacin, metronidazole, amoxicillin，tetracycline，furazolidone and the dose of esomeprazole (Device)
The refractory infection of H. pylori group
The patients with first eradication therapy of H. pylori infection have the two failure treatment based on the standardized treatment including antibiotics selection from antibiotic susceptibility testing and PPIs dose selection from CYP2C19 gene sequencing.
干预措施: The result of Amoxicillin resistance in vitro based on antibiotic susceptibility testing (Device)
结局指标
主要结局
The microflora structure of a total of 240 patients in the first successful eradication group and the refractory infection of H. pylori group
时间窗: Three months
The eradication rate of H. pylori reach to 95% in all groups
时间窗: 1 year
The proportion of mix infection of H pylori in a total of 240 patients in two groups
时间窗: Three months
The number of single nucleotide varation（SNV）of 20 patients in the first successful eradication group and the refractory infection of H. pylori group that are related to Amoxicillin resistance
时间窗: Three months
次要结局
未报告次要终点
研究者
Liping Ye
Director of the Department of Gastroenterology
Taizhou Hospital