Comparing the Efficacy of Reverse Hybrid Therapy and Bismuth Quadruple Therapy

Study Overview
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Brief Summary
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Reverse hybrid therapy achieves a higher eradication rate than bismuth quadruple therapy remained unanswered.

Detailed Description
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A 14-day hybrid therapy invented by our study group appears very promising in H. pylori eradication, achieving excellent eradication rates of 99% and 97% according to per-protocol and intention-to-treat analyses, respectively. Recently, the investigators demonstrated that the eradication rate of reverse hybrid therapy was higher than that of standard triple therapy. However, whether reverse hybrid therapy achieves a higher eradication rate than bismuth quadruple therapy remained unanswered.

Official Title
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Comparing the Efficacy and Impact on Gastrointestinal Microbiome of Reverse Hybrid Therapy and Bismuth Quadruple Therapy in Helicobacter Pylori Eradication

Conditions
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Helicobacter Pylori Infection

Intervention / Treatment
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* Drug: pantoprazole+bismuth+tetra+metro
* Drug: (panto+amox+clar+metr)+(panto+amox)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Consecutive H pylori-infected outpatients, at least 20 years of age, with endoscopically proven peptic ulcer diseases or gastritis Exclusion Criteria: previous H pylori-eradication therapy ingestion of antibiotics or bismuth 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: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: pantoprazole+bismuth+tetra+metro<br>pantoprazole 40 mg twice daily, bismuth subcitrate 120 mg four times daily, and tetracycline 500 mg four times daily, and metronidazole 250 mg four times daily for 14 days | Drug: pantoprazole+bismuth+tetra+metro<br>* pantoprazole 40 mg twice daily, bismuth subcitrate 120 mg four times daily, and tetracycline 500 mg four times daily, and metronidazole 250 mg four times daily for 14 days<br>* Other names: metronidazole 250 mg;|
| Active Comparator: (panto+amox+clar+metr)+(panto+amox)<br>a 7-day quadruple regimen with pantoprazole 40 mg twice daily, amoxicillin 1 g twice daily, clarithromycin 500 mg twice daily, and metronidazole 500 mg twice daily, followed by a 7-day dual regimen with pantoprazole 40 mg twice daily and amoxicillin 1 g twice daily | Drug: (panto+amox+clar+metr)+(panto+amox)<br>* a 7-day quadruple regimen with pantoprazole 40 mg twice daily, amoxicillin 1 g twice daily, clarithromycin 500 mg twice daily, and metronidazole 500 mg twice daily, followed by a 7-day dual regimen with pantoprazole 40 mg twice daily and amoxicillin 1 g twice daily<br>* Other names: metronidazole 500 mg;|

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 | Evaluate eradication outcome by endoscopy urease test and histology or urea breath test (Number of Participants With Complete Eradication of Helicobacter Pylori) | sixth week 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 rate, Helicobacter pylori