Personalized Treatment for Refractory H Pylori Infection

Study Overview
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Brief Summary
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In this study, the investigators develop a personalized treatment according to culture-guided antibiotics plus high-dose proton-pump inhibitor and bismuth to treat refractory H pylori infection.

Detailed Description
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They are categorized into three groups: (1) patients who have positive result of culture with equal to or more than three susceptible antibiotics are treated by non-bismuth quadruple therapy (rabeprazole 20 mg q.d.s. and three effective antibiotics), (2) patients who have positive result of culture with one or two susceptible antibiotics are treated by bismuth-containing therapy (rabeprazole 20 mg q.d.s., bismuth subcitrate 120 mg q.d.s. and all the effective antibiotics), and (3) patients who have negative result of culture or whose culture data are unavailable will be treated by (rabeprazole 20 mg q.d.s, amoxicillin 500 mg q.d.s., tetracycline 500 mg q.d.s. and levofloxacin 500 mg o.d.) for 14 days.

Official Title
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Personalized Treatment for Refractory H Pylori Infection

Conditions
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Helicobacter Pylori Infection

Intervention / Treatment
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* Drug: rabeprazole+3 antibiotics
* Drug: rabeprazole+bismuth+2 antibiotics
* Drug: rabeprazole+amox+tetr+levo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: H pylori-infected adult patients with at least two previous failed eradication attempts will be enrolled in this study after giving informed consent. positive results of both rapid urease test and histology, a positive result of Urea breath test, or a positive result of culture Exclusion Criteria: ingestion of antibiotics, bismuth, or proton-pump inhibitor within the prior 4 weeks, patients with allergic history to the medications used, patients with previous gastric surgery, the coexistence of serious concomitant illness (for example, decompensated liver cirrhosis, uremia), pregnant women.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: rabeprazole+3 antibiotics<br>patients who have positive result of culture with equal to or more than three susceptible antibiotics are treated by non-bismuth quadruple therapy (rabeprazole 20 mg q.d.s. and three effective antibiotics) for 14 days | Drug: rabeprazole+3 antibiotics<br>* (rabeprazole 20 mg q.d.s. and three effective antibiotics) for 14 days.<br>* Other names: levofloxacin 500mg;|
| Experimental: rabeprazole+bismuth+2 antibiotics<br>patients who have positive result of culture with one or two susceptible antibiotics are treated by bismuth-containing therapy (rabeprazole 20 mg q.d.s., bismuth subcitrate 120 mg q.d.s. and all the effective antibiotics) for 14 days | Drug: rabeprazole+bismuth+2 antibiotics<br>* (rabeprazole 20 mg q.d.s., bismuth subcitrate 120 mg q.d.s. and all the effective antibiotics) for 14 days.<br>* Other names: levofloxacin 500mg;|
| Active Comparator: rabeprazole+amox+tetr+levo<br>patients who have negative result of culture or whose culture data are unavailable will be treated by (rabeprazole 20 mg q.d.s, amoxicillin 500 mg q.d.s., tetracycline 500 mg q.d.s. and levofloxacin 500 mg o.d.) for 14 days | Drug: rabeprazole+amox+tetr+levo<br>* (rabeprazole 20 mg q.d.s, amoxicillin 500 mg q.d.s., tetracycline 500 mg q.d.s. and levofloxacin 500 mg o.d.) for 14 days.<br>* Other names: levofloxacin 500mg;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants in Which H. Pylori Was Eradicated | To assess eradication efficacy,repeated endoscopy with rapid urease test, histological examination and culture or Urea breath test. | eight weeks after the end of anti-H pylori therapy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Eradication, Helicobacter pylori, third-line therapy, antibiotic susceptibility