A Multi-center Study for Eradication of Helicobacter Pylori With Triple Therapy Using Clarithromycin
NCT ID: NCT02923856
Last Updated: 2019-02-19
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
672 participants
INTERVENTIONAL
2017-01-31
2019-12-31
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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Clarithromycin resistance group
Patients who are resistant to clarithromycin in susceptibility test were classified into clarithromycin resistance group.
The results of clarithromycin susceptibility test of H. pylori isolates
According to the results of antibiotic susceptible testing, patients who were resistant to clarithromycin were belonged into clarithromycin resistance group.Patients who were sensitive to clarithromycin were belonged into the 7days/10days/14days treatment groups.
7 days Successful treatment
The successful treatment of H. pylori group were treatment successful patients after the 7days standardized treatment.
The results of clarithromycin susceptibility test of H. pylori isolates
According to the results of antibiotic susceptible testing, patients who were resistant to clarithromycin were belonged into clarithromycin resistance group.Patients who were sensitive to clarithromycin were belonged into the 7days/10days/14days treatment groups.
Computer generated random number, randomly assigned into groups
The patients with clarithromycin sensitive. Computer generated random number,randomly assigned into 7days/10days/14days treatment groups.
The result of 13C-urea breath test of patient in 7days/10days/14days treatment groups
The intervention focused on the results from the result of 13C-urea breath test at 8 weeks after treatment in patients. All patients were taking 75mg 13C-urea and analysis with a modified isotope ratio mass spectrometer to determine the 13CO2 content.The successful treatment groups were patients with negative in 13C-urea breath tests.The failed treatment of H. pylori groups were patients with positive in 13C-urea breath tests after the standardized triple therapy treatment.
7 days failed treatment
The failed treatment of H. pylori group were treatment failure patients after the 7days standardized treatment.
The results of clarithromycin susceptibility test of H. pylori isolates
According to the results of antibiotic susceptible testing, patients who were resistant to clarithromycin were belonged into clarithromycin resistance group.Patients who were sensitive to clarithromycin were belonged into the 7days/10days/14days treatment groups.
Computer generated random number, randomly assigned into groups
The patients with clarithromycin sensitive. Computer generated random number,randomly assigned into 7days/10days/14days treatment groups.
The result of 13C-urea breath test of patient in 7days/10days/14days treatment groups
The intervention focused on the results from the result of 13C-urea breath test at 8 weeks after treatment in patients. All patients were taking 75mg 13C-urea and analysis with a modified isotope ratio mass spectrometer to determine the 13CO2 content.The successful treatment groups were patients with negative in 13C-urea breath tests.The failed treatment of H. pylori groups were patients with positive in 13C-urea breath tests after the standardized triple therapy treatment.
10 days Successful treatment
The successful treatment of H. pylori group were treatment successful patients after the 10days standardized treatment.
The results of clarithromycin susceptibility test of H. pylori isolates
According to the results of antibiotic susceptible testing, patients who were resistant to clarithromycin were belonged into clarithromycin resistance group.Patients who were sensitive to clarithromycin were belonged into the 7days/10days/14days treatment groups.
Computer generated random number, randomly assigned into groups
The patients with clarithromycin sensitive. Computer generated random number,randomly assigned into 7days/10days/14days treatment groups.
The result of 13C-urea breath test of patient in 7days/10days/14days treatment groups
The intervention focused on the results from the result of 13C-urea breath test at 8 weeks after treatment in patients. All patients were taking 75mg 13C-urea and analysis with a modified isotope ratio mass spectrometer to determine the 13CO2 content.The successful treatment groups were patients with negative in 13C-urea breath tests.The failed treatment of H. pylori groups were patients with positive in 13C-urea breath tests after the standardized triple therapy treatment.
10 days failed treatment
The failed treatment of H. pylori group were treatment failure patients after the 10days standardized treatment.
The results of clarithromycin susceptibility test of H. pylori isolates
According to the results of antibiotic susceptible testing, patients who were resistant to clarithromycin were belonged into clarithromycin resistance group.Patients who were sensitive to clarithromycin were belonged into the 7days/10days/14days treatment groups.
Computer generated random number, randomly assigned into groups
The patients with clarithromycin sensitive. Computer generated random number,randomly assigned into 7days/10days/14days treatment groups.
The result of 13C-urea breath test of patient in 7days/10days/14days treatment groups
The intervention focused on the results from the result of 13C-urea breath test at 8 weeks after treatment in patients. All patients were taking 75mg 13C-urea and analysis with a modified isotope ratio mass spectrometer to determine the 13CO2 content.The successful treatment groups were patients with negative in 13C-urea breath tests.The failed treatment of H. pylori groups were patients with positive in 13C-urea breath tests after the standardized triple therapy treatment.
14 days Successful treatment
The successful treatment of H. pylori group were treatment successful patients after the 14days standardized treatment.
The results of clarithromycin susceptibility test of H. pylori isolates
According to the results of antibiotic susceptible testing, patients who were resistant to clarithromycin were belonged into clarithromycin resistance group.Patients who were sensitive to clarithromycin were belonged into the 7days/10days/14days treatment groups.
Computer generated random number, randomly assigned into groups
The patients with clarithromycin sensitive. Computer generated random number,randomly assigned into 7days/10days/14days treatment groups.
The result of 13C-urea breath test of patient in 7days/10days/14days treatment groups
The intervention focused on the results from the result of 13C-urea breath test at 8 weeks after treatment in patients. All patients were taking 75mg 13C-urea and analysis with a modified isotope ratio mass spectrometer to determine the 13CO2 content.The successful treatment groups were patients with negative in 13C-urea breath tests.The failed treatment of H. pylori groups were patients with positive in 13C-urea breath tests after the standardized triple therapy treatment.
14 days failed treatment
The failed treatment of H. pylori group were treatment failure patients after the 14days standardized treatment.
The results of clarithromycin susceptibility test of H. pylori isolates
According to the results of antibiotic susceptible testing, patients who were resistant to clarithromycin were belonged into clarithromycin resistance group.Patients who were sensitive to clarithromycin were belonged into the 7days/10days/14days treatment groups.
Computer generated random number, randomly assigned into groups
The patients with clarithromycin sensitive. Computer generated random number,randomly assigned into 7days/10days/14days treatment groups.
The result of 13C-urea breath test of patient in 7days/10days/14days treatment groups
The intervention focused on the results from the result of 13C-urea breath test at 8 weeks after treatment in patients. All patients were taking 75mg 13C-urea and analysis with a modified isotope ratio mass spectrometer to determine the 13CO2 content.The successful treatment groups were patients with negative in 13C-urea breath tests.The failed treatment of H. pylori groups were patients with positive in 13C-urea breath tests after the standardized triple therapy treatment.
Interventions
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The results of clarithromycin susceptibility test of H. pylori isolates
According to the results of antibiotic susceptible testing, patients who were resistant to clarithromycin were belonged into clarithromycin resistance group.Patients who were sensitive to clarithromycin were belonged into the 7days/10days/14days treatment groups.
Computer generated random number, randomly assigned into groups
The patients with clarithromycin sensitive. Computer generated random number,randomly assigned into 7days/10days/14days treatment groups.
The result of 13C-urea breath test of patient in 7days/10days/14days treatment groups
The intervention focused on the results from the result of 13C-urea breath test at 8 weeks after treatment in patients. All patients were taking 75mg 13C-urea and analysis with a modified isotope ratio mass spectrometer to determine the 13CO2 content.The successful treatment groups were patients with negative in 13C-urea breath tests.The failed treatment of H. pylori groups were patients with positive in 13C-urea breath tests after the standardized triple therapy treatment.
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 PPI 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. Within 3 months before with the drugs involved in other drugs research.
5. Esophageal,gastrointestinal surgery history.
6. Patients can not properly express their complaints,such as psychosis, severe neurosis.
7. Taking NSIAD or alcohol abusers.
8. Allergic to amoxicillin or clarithromycin tested by susceptibility testing.
18 Years
70 Years
ALL
No
Sponsors
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Wenzhou Central Hospital
OTHER
The First Affiliated Hospital with Nanjing Medical University
OTHER
Taizhou Hospital
OTHER
Affiliated Wenling Hospital of Wenzhou Medical University
OTHER
Hangzhou Medical College
OTHER
Centers for Disease Control and Prevention, China
OTHER_GOV
Zhiyuan Medical Inspection Institute
OTHER
Sanmen People's Hospital
OTHER
Responsible Party
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Hongzhang Li
Director of Sanmen People's Hospital
Locations
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Sanmen People's hospital
Taizhou, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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SanmenPH
Identifier Type: -
Identifier Source: org_study_id
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