Tailored Versus Empiric Therapy for Helicobacter Pylori Treatment
NCT ID: NCT02935010
Last Updated: 2018-08-15
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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COMPLETED
PHASE4
382 participants
INTERVENTIONAL
2017-02-05
2018-03-31
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
SINGLE
Study Groups
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Tailored therapy
After antimicrobial susceptibility testing of Helicobacter pylori from biopsy samples, according to antibiotic resistance pattern of each one, give esomeprazole 20mg bid and two sensitive ones of amoxicillin,clarithromycin, metronidazole,and levofloxacin. All regimens will be given for 14 days.
Esomeprazole
proton pump inhibitor
Bismuth Potassium Citrate
Gastric mucosal protective drug with anti-H. pylori effect
Amoxicillin
antibiotic for H. pylori eradication
Clarithromycin
antibiotic for H. pylori eradication
Metronidazole
antibiotic for H. pylori eradication
Levofloxacin
antibiotic for H. pylori eradication
Empiric therapy
give esomeprazole 20mg bid, bismuth potassium citrate 600mg bid, amoxicillin 1000mg tid and metronidazole 400mg tid for 14 days
Esomeprazole
proton pump inhibitor
Bismuth Potassium Citrate
Gastric mucosal protective drug with anti-H. pylori effect
Amoxicillin
antibiotic for H. pylori eradication
Metronidazole
antibiotic for H. pylori eradication
Interventions
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Esomeprazole
proton pump inhibitor
Bismuth Potassium Citrate
Gastric mucosal protective drug with anti-H. pylori effect
Amoxicillin
antibiotic for H. pylori eradication
Clarithromycin
antibiotic for H. pylori eradication
Metronidazole
antibiotic for H. pylori eradication
Levofloxacin
antibiotic for H. pylori eradication
Eligibility Criteria
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Inclusion Criteria
* Ability and willingness to participate in the study and to sign and give informed consent
* confirmed H. pylori infection
Exclusion Criteria
* Less than 18 years old
* With history of H. pylori infection treatment
* With previous gastric surgery
* Major systemic diseases
* Pregnancy or lactation
* Allergy to any of the study drugs
* Administration of antibiotics, bismuth, antisecretory drugs in 8 weeks prior to inclusion
18 Years
ALL
No
Sponsors
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Shanghai Jiao Tong University School of Medicine
OTHER
Responsible Party
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Hong Lu, MD
Doctor
Principal Investigators
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Hong Lu, M.D.
Role: STUDY_CHAIR
Renji Hospital, School of Medicine, Shanghai Jiao Tong University
Yunwei Sun, M.D.
Role: PRINCIPAL_INVESTIGATOR
Ruijin Hospital
Hong Gao, M.D.
Role: PRINCIPAL_INVESTIGATOR
Fudan University
Yan Zhao, M.D.
Role: PRINCIPAL_INVESTIGATOR
Shanghai Tenth People's Hospital, Tongji University
Gang Xu, M.D.
Role: PRINCIPAL_INVESTIGATOR
Shanghai General Hospital, Shanghai First People's Hospital, Shanghai Jiao Tong University
Locations
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Ruijin Hospital, School of Medicine, Shanghai Jiao Tong University
Shanghai, Shanghai Municipality, China
Shanghai General Hospital, Shanghai First People's Hospital, Shanghai Jiao Tong University
Shanghai, Shanghai Municipality, China
Shanghai Tenth People's Hospital, Tongji University
Shanghai, Shanghai Municipality, China
Zhongshan Hospital,Fudan University
Shanghai, Shanghai Municipality, China
Renji Hospital, School of Medicine, Shanghai Jiao Tong University
Shanghai, Shanghai Municipality, China
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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rjkls2016110
Identifier Type: -
Identifier Source: org_study_id
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