Gastritis
Conditions
Keywords
Helicobacter pylori, Antibiotic resistance, Sequencing, Mechanism
Brief summary
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.
Interventions
DEVICEThe result of H pylori culture based on gram staining and enzyme activity testing
This intervention aimed at patients with the positive result of 13C-urea breath test. Patients with negative result of H pylori culture was H pylori culture negative group. Patients with positive result of H pylori culture were belonged into the first successful eradication group and the refractory infection of H. pylori group.
DEVICEThe result of 13C-urea breath test after treatment based on the selection of clarithromycin, levofloxacin, metronidazole, amoxicillin，tetracycline，furazolidone and the dose of esomeprazole
The intervention focused on the results from the result of 13C-urea breath test after treatment. The first successful eradication group and the refractory infection of H. pylori group were treated according to the antibiotic susceptibility testing and CYP2C19 gene polymorphism. Eight weeks after treatment, a 13C-urea breath test was performed on patients. The first successful eradication group were patients with negative in 13C-urea breath tests in the first treatment. The refractory infection of H. pylori group were treatment failure patients with positive in 13C-urea breath tests after the second standardized treatment.
DEVICEThe result of Amoxicillin resistance in vitro based on antibiotic susceptibility testing
The intervention focused on the results from the result of Amoxicillin susceptibility testing in vitro. In this study, the investigators selected the patients with Amoxicillin resistance from the first successful eradication group and the refractory infection of H. pylori group.
Sponsors
Centers for Disease Control and Prevention, China
Academy Military Medical Science, China
First Affiliated Hospital of Zhejiang University
Taizhou Enze Medical Center Group
Taizhou First People's Hospital
The first people Hospital of Linhai
Affiliated Wenling Hospital of Wenzhou Medical University
Sanmen People Hospital
Xianju People Hospital
Tiantai People Hospital
Yuhuan People Hospital
The second people Hospital of Yuhuan
Zhiyuan Medical Inspection Institute
Taizhou Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Age 18\ 70 years old, male or female, the first eradication therapy of H. pylori infection patients. 2. Symptoms of abdominal pain, bloating, acid efflux, belching, nausea, vomiting, heartburn, chest pain, vomiting, melena, etc. 3. Unused antibiotics, bismuth, H2 receptor antagonists or PPIs by nearly 4 weeks 4. 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.
Exclusion criteria
1. Severe heart, liver, kidney dysfunction. 2. Pregnant or lactating women. 3. Complications of bleeding, perforation, pyloric obstruction, cancer. 4. Esophageal,gastrointestinal surgery history. 5. Patients can not properly express their complaints,such as psychosis, severe neurosis. 6. Taking nonsteroidal antiinflammatory drugs (NSAIDs) or alcohol abusers. 7. Allergic to penicillin or either drugs of the 6 antibiotic tested by susceptibility testing.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The eradication rate of H. pylori reach to 95% in all groups | 1 year |
| The microflora structure of a total of 240 patients in the first successful eradication group and the refractory infection of H. pylori group | Three months |
| The proportion of mix infection of H pylori in a total of 240 patients in two groups | 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 | Three months |
Countries
China
Contacts
Primary ContactLiping Ye, BSc
Outcome results
None listed