A Multi-center Study for Eradication of Refractory Helicobacter Pylori
NCT ID: NCT02741414
Last Updated: 2016-07-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
4428 participants
INTERVENTIONAL
2016-06-30
2018-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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H pylori culture negative group
The patients who have the negative result of H pylori culture were classified into H pylori culture negative group.
The 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.
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.
The 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.
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
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.
The 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.
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.
The 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.
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
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.
The 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.
Interventions
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The 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.
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
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.
The 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.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
70 Years
ALL
No
Sponsors
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Centers for Disease Control and Prevention, China
OTHER_GOV
Academy Military Medical Science, China
INDUSTRY
First Affiliated Hospital of Zhejiang University
OTHER
Taizhou Enze Medical Center Group
OTHER
Taizhou First People's Hospital
OTHER
The first people Hospital of Linhai
UNKNOWN
Affiliated Wenling Hospital of Wenzhou Medical University
OTHER
Sanmen People Hospital
UNKNOWN
Xianju People Hospital
UNKNOWN
Tiantai People Hospital
UNKNOWN
Yuhuan People Hospital
UNKNOWN
The second people Hospital of Yuhuan
UNKNOWN
Zhiyuan Medical Inspection Institute
OTHER
Taizhou Hospital
OTHER
Responsible Party
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Liping Ye
Director of the Department of Gastroenterology
Locations
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Xianju People Hospital
Taizhou, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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Hong Li Lyh
Role: primary
Other Identifiers
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TaizhouH
Identifier Type: -
Identifier Source: org_study_id
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