Tailored Versus Empiric Therapy for Helicobacter Pylori Treatment
- Conditions
- Helicobacter Pylori Infection
- Interventions
- Registration Number
- NCT02935010
- Lead Sponsor
- Shanghai Jiao Tong University School of Medicine
- Brief Summary
With markedly increased antibiotic resistance and unsatisfactory efficacies of common empiric eradication regimens in the mainland of China, tailored therapy may be the best choice to achieve good efficacy. This study compared the eradication rates, safety, and compliance of antibiotic sensitivity-based tailored therapy compared with empiric bismuth quadruple therapy in the naive patients with Helicobacter pylori infection.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 382
- Participants with non-ulcer functional dyspepsia or scarred peptic ulcer disease
- Ability and willingness to participate in the study and to sign and give informed consent
- confirmed H. pylori infection
- Previous H. pylori eradication therapy
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Tailored therapy Esomeprazole 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. Empiric therapy Esomeprazole give esomeprazole 20mg bid, bismuth potassium citrate 600mg bid, amoxicillin 1000mg tid and metronidazole 400mg tid for 14 days Empiric therapy Metronidazole give esomeprazole 20mg bid, bismuth potassium citrate 600mg bid, amoxicillin 1000mg tid and metronidazole 400mg tid for 14 days Empiric therapy Bismuth Potassium Citrate give esomeprazole 20mg bid, bismuth potassium citrate 600mg bid, amoxicillin 1000mg tid and metronidazole 400mg tid for 14 days Tailored therapy Bismuth Potassium Citrate 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. Tailored therapy Amoxicillin 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. Tailored therapy Clarithromycin 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. Tailored therapy Metronidazole 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. Tailored therapy Levofloxacin 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. Empiric therapy Amoxicillin give esomeprazole 20mg bid, bismuth potassium citrate 600mg bid, amoxicillin 1000mg tid and metronidazole 400mg tid for 14 days
- Primary Outcome Measures
Name Time Method Helicobacter pylori eradication rate Six weeks after completion of therapy Six weeks after completion of therapy, H. pylori eradication was assessed by ¹³C-urea breath test. Eradication was defined as negative result from urea breath test (\<4‰) (4‰ as the cutoff value).
- Secondary Outcome Measures
Name Time Method Compliance rate within 7 days after completion of therapy Compliance was defined as poor when they had taken less than 80% of the total medication.
Rate of adverse effects within 7 days after completion of therapy During the 14-day treatment period, the subjects kept a diary to score any possible side effects or discomforts. The subjects were asked to grade the severity of adverse events according to their influence on daily activities, experienced as "mild" (transient and well tolerated), "moderate" (causing discomfort and partially interfering with daily activities), or "severe" (causing considerable interference with daily activities). The side effect score recorded was based on the most severe event.
Trial Locations
- Locations (5)
Shanghai General Hospital, Shanghai First People's Hospital, Shanghai Jiao Tong University
🇨🇳Shanghai, Shanghai, China
Zhongshan Hospital,Fudan University
🇨🇳Shanghai, Shanghai, China
Shanghai Tenth People's Hospital, Tongji University
🇨🇳Shanghai, Shanghai, China
Renji Hospital, School of Medicine, Shanghai Jiao Tong University
🇨🇳Shanghai, Shanghai, China
Ruijin Hospital, School of Medicine, Shanghai Jiao Tong University
🇨🇳Shanghai, Shanghai, China