Comparison Between Ten Days Sequential Treatment and Traditional Three Combined Treatment of Helicobacter Pylori

Study Overview
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Brief Summary
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The purpose of this study is to compare the eradication efficacy of 10-day triple therapy with 10-day sequential therapy with tetracycline or metronidazole.

Detailed Description
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Background: Antimicrobial resistance has decreased eradication rates for Helicobacter pylori infection worldwide. Objective: To determine whether sequential treatment eradicates H. pylori infection better than standard triple-drug therapy for adults with dyspepsia or peptic ulcers in Taiwanese people. Design: Randomized, single-blind, prospective controlled trial. Setting: A large tertiary referral hospital in eastern Taiwan. Patients: 450 patients with dyspepsia or peptic ulcers and infected by H. pylori. Measurements: 13C-urea breath test, upper endoscopy, histologic evaluation, rapid urease test, bacterial culture, assessment of antibiotic resistance and CYP2C19 genotype of host. Intervention: 450 patients with H. pylori infection are randomly assigned to receive one of the following therapeutic schemes: group A (5RA5RCT): rabeprazole (20 mg bid) plus amoxicillin (1 g bid) for 5 days, followed by rabeprazole (20 mg bid) plus clarithromycin (500 mg bid) and tetracycline (1g bid) for a further 5 days; group B (5RA5RCM): rabeprazole (20 mg bid) plus amoxicillin (1 g bid) for 5 days, followed by rabeprazole (20 mg bid) plus clarithromycin (500 mg bid) and metronidazole (500mg bid) for a further 5 days; group C as control: rabeprazole (20 mg bid) plus amoxicillin (1 g bid) and clarithromycin (500 mg bid.) for 10 days.

Official Title
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Comparison Between Ten Days Sequential Treatment (With Metronidazole or Tetracycline) and Ten Days Standard Triple Therapy of Helicobacter Pylori

Conditions
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Helicobacter Pylori Infection

Intervention / Treatment
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* Drug: 5RA-5RCM
* Drug: 5RA-5RCT
* Drug: 10RCA


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patient proved with infection of H. pylori in gastric mucosa adult with signed inform consent Exclusion Criteria: woman in breast feeding or pregnancy. allergy to drugs used in study. three months without use of any antibiotic agents. patients under 20 years old.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 95 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: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Seq-Metronidazole<br>10-day sequential therapy with metronidazole | Drug: 5RA-5RCM<br>* rabeprazole 20mg b.i.d + amoxicillin 1000mg b.i.d x 5 days + rabeprazole 20mg b.i.d + clarithromycin 500mg b.i.d + metronidazole 500mg b.i.d x last 5 days.<br>* Other names: Flagyl x last 5 days;|
| Experimental: Seq-Tetracycline<br>10-day sequential therapy with tetracycline. | Drug: 5RA-5RCT<br>* rabeprazole 20mg b.i.d + amoxicillin 1000mg b.i.d x 5 days + rabeprazole 20mg b.i.d + clarithromycin 500mg b.i.d + tetracycline 1000mg b.i.d x last 5 days.<br>* Other names: Acromycin x last 5 days.;|
| Active Comparator: Control<br>10-day standard triple therapy. | Drug: 10RCA<br>* rabeprazole 20mg b.i.d + clarithromycin 500mg b.i.d + amoxicillin 1000mg b.i.d x 10 days.<br>* Other names: Hiconcil x 10 days.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Eradication rate | A negative post-treatment 13C-urea breath test or CLO test result at more than 4 weeks after complete use of drug for treatment | 4 weeks after complete use of drug for treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Helicobacter pylori, antibiotic resistance, sequential therapy, Taiwan