A Relevance Study Between the Result of Clinical Drug Intervention and Next-generation Sequencing Technology Focused on Refractory Helicobacter Pylori Infection
NCT ID: NCT02806674
Last Updated: 2017-10-31
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
1845 participants
INTERVENTIONAL
2016-07-31
2019-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Successful treatment
The eradication times of the patients
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
The result of 13C-urea breath test after treatment
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.
Refractory infection of H.pylori
The eradication times of the patients
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
The result of 13C-urea breath test after treatment
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.
Interventions
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The eradication times of the patients
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
The result of 13C-urea breath test after treatment
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.
Eligibility Criteria
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Inclusion Criteria
2. Symptoms of abdominal pain, bloating, acid reflux,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. Esophageal,gastrointestinal surgery history.
5. Patients can not properly express their complaints,such as psychosis, severe neurosis.
6. Taking NSIAD 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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People Hospital of Luohu,Shenzhen
UNKNOWN
Shenzhen Second People's Hospital
OTHER
Longhua Branch of Shenzhen People Hospital
UNKNOWN
The People Hospital of Baoan Shenzhen
OTHER
Zhiyuan Medical Inspection Institute
OTHER
The University of Hong Kong-Shenzhen Hospital
OTHER
Responsible Party
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TaoLYU
Deputy Director of the Department of Gastroenterology
Principal Investigators
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Tao Lyu, Doctor
Role: PRINCIPAL_INVESTIGATOR
The University of HongKong-Shenzhen Hospital
Locations
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The People Hospital of Baoan Shenzhen
Shenzhen, Guangdong, China
Longhua Branch of Shenzhen People Hospital
Shenzhen, Guangdong, China
People Hospital of Luohu,Shenzhen
Shenzhen, Guangdong, China
Shenzhen Second People's Hospital
Shenzhen, Guangdong, China
Countries
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Central Contacts
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Facility Contacts
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Wei Jian Wu
Role: primary
Peng Yin Li, Doctor
Role: primary
Qiu Xi Yu, Doctor
Role: primary
Jun Liu, Master
Role: primary
Jian Hai Guo, Doctor
Role: backup
Other Identifiers
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UHongKongShenzhen
Identifier Type: -
Identifier Source: org_study_id