A Relevance Study Between the Result of Clinical Drug Intervention and Next-generation Sequencing Technology Focused on Refractory Helicobacter Pylori Infection

Study Overview
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Brief Summary
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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.

Official Title
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A Relevance Study Between the Result of Clinical Drug Intervention and Next-generation Sequencing Technology Focused on Refractory Helicobacter Pylori Infection

Conditions
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Gastritis

Intervention / Treatment
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* Device: The eradication times of the patients
* Device: The result of 13C-urea breath test after treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Successful treatment<br> | Device: The eradication times of the patients<br>* The patients who have failed more than 2 eradication courses with standardized treatment were the refractory infection of H. pylori group,and patients who succeeded at the first standardized treatment were the successful treatment group<br>Device: The result of 13C-urea breath test after treatment<br>* The intervention focused on the results from the result of 13C-urea breath test after treatment.The two groups were treatment based on the antibiotic susceptibility testing. Eight weeks after treatment,a 13C-urea breath test was performed on patients.The successful treatment 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 after the second standardized treatment.<br>|
| Experimental: Refractory infection of H.pylori<br> | Device: The eradication times of the patients<br>* The patients who have failed more than 2 eradication courses with standardized treatment were the refractory infection of H. pylori group,and patients who succeeded at the first standardized treatment were the successful treatment group<br>Device: The result of 13C-urea breath test after treatment<br>* The intervention focused on the results from the result of 13C-urea breath test after treatment.The two groups were treatment based on the antibiotic susceptibility testing. Eight weeks after treatment,a 13C-urea breath test was performed on patients.The successful treatment 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 after the second standardized treatment.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The eradication rate of H. pylori reach to 95% | The eradication rate of untreated cases reach to 98%.The eradication rate of refractory cases reach to 90%. | 1.5 year | 
| Obtain the first resistant pattern to antibiotics in shenzhen area | 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. | 1.5 year | 
| The proportion of mix infection of H pylori in a total of 40 patients in two groups | Analyzed the next-generation sequencing data,obtain the proportion of mixed infection with different H. pylori strain in refractory cases. | 2.5 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of adverse effects in the eradicate treatment | A telephone interview was conducted at 4 weeks after treatment.And the 1845 patients was investigated using questionnaires of symptom checklist.A statistics table will be got. | 2.5 year | 
| The difference between microbial genes of different patients | By 2 or 3 metabolic pathways with significant differences, selected 40-50 different genes. | 3 year | 
| The relevance between mixed infection, microflora structure and risk factors | Analyzed the next-generation sequencing data,obtain the results of mixed infection and microflora structure in a total of 40 patients in two groups.And the patients was investigated using questionnaires of risk checklist.The collected data were subsequently analyzed using SPSS. For checking the relationship between mixed infection, microflora structure and risk factors. | 3 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Helicobacter pylori, Antibiotic resistance, Sequencing