Efficacy of High-dose Dual Therapy vs Bismuth-containing Quadruple Therapy for First-line Treatment of Hp Infection

Study Overview
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Brief Summary
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Up to now, there is few randomized, large scale study prospectively and simultaneously comparing the efficacy, adverse effects and patient adherence of high-dose dual therapy (HDDT) and bismuth-containing quadruple therapy (BQT) as 1st-line regimens for H. pylori eradication. The aims of this study are: to compare the efficacy of HDDT, and BQT as 1st-line regimen in H. pylori eradication; to compare the patient adherence and adverse effects of these treatment regimens; to investigate factors that may influence H. pylori eradication by these treatment regimens.

Detailed Description
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Participants, aged ≥ 20, having H. pylori-positive chronic gastritis with/without peptic ulcers (duodenal or gastric ulcers) will be recruited. All undergo endoscopy with biopsy for rapid urease teat, histology, and bacterial culture before treatment. Four to eight weeks after termination of treatment, H. pylori infection status will be examined by the 13C-urea breath test. The CYP2C19 genotype of each participant will be analyzed by the polymerase chain reaction-based restriction fragment length polymerase (PCR-RFLP) method. A computed generated random numbers sequence will be blocked into two subgroups, say A, and B. If the participants did not receive anti-H. pylori therapy previously, they will be invited to enter this study for evaluated the efficacy of these 1st-line regimens. Participant who meet the inclusion criteria and do not have any one of the exclusion criteria will be randomized to receive one of the following regimens: group A- HDDT (rabeprazole 20 mg qid + amoxicillin 750 mg qid for 14 days); group B- BQT ( rabeprazole 20 mg qid + tripotassium dicitrate bismuthate 300 mg qid + metronidazole 250 mg qid + tetracycline 500 mg qid for 10 days); All participants will be asked to complete a questionnaire and to record symptoms and drug consumption daily during the treatment period. Post-treatment, the participants will be followed up at the Outpatients Clinic to investigate patient adherence and adverse effect of treatment.

Official Title
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Efficacy of High-dose Dual Therapy Versus Bismuth-containing Quadruple Therapy for First-line Treatment of Helicobacter Pylori Infection - A Prospective, Randomized, Comparative Study

Conditions
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Helicobacter Pylori Infection

Intervention / Treatment
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* Drug: High-dose dual therapy (rabeprazole, amoxicillin)
* Drug: Bismuth-containing quadruple therapy (rabeprazole, tripotassium dicitrate bismuthate, metronidazole, tetracycline)


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Participants having H. pylori related chronic gastritis with/without peptic ulcers who are aged greater than 20 years old and are willing to received eradication therapy. Exclusion criteria: pregnant or nursing woman serious concomitant illness and malignant tumor of any kind history of hypersensitivity to test drugs serious bleeding during the course of the ulcer previous gastric surgery receiving bismuth salts, PPIs, or antibiotics in the previous month.

Ages Eligible for Study
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Minimum Age: 20 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: High-dose dual therapy<br>group A-high-dose dual therapy ( rabeprazole 20 mg, tablet, qid + amoxicillin 750 mg, capsule, qid for 14 days) | Drug: High-dose dual therapy (rabeprazole, amoxicillin)<br>* High-dose dual therapy ( rabeprazole 20 mg qid + amoxicillin 750 mg qid for 14 days)<br>* Other names: Antibiotics, Amoxicillin ,Amoxicillin®;|
| Active Comparator: Bismuth-containing quadruple therapy<br>group B-bismuth-containing quadruple therapy (rabeprazole 20 mg, tablet, bid + tripotassium dicitrate bismuthate 300 mg, tablet, qid + metronidazole 250 mg, tablet, qid + tetracycline 500 mg qid, capsule, for 10 days) | Drug: Bismuth-containing quadruple therapy (rabeprazole, tripotassium dicitrate bismuthate, metronidazole, tetracycline)<br>* Bismuth-containing quadruple therapy (rabeprazole 20 mg bid + tripotassium dicitrate bismuthate 300 mg qid + metronidazole 250 mg qid + tetracycline 500 mg qid for 10 days)<br>* Other names: Colloidal Bismuth, Tripotassium dicitrate bismuthate, KCB®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The eradication rates as a measure of the efficacy of HDDT, and BQT | The eradication rates (efficacy) will be evaluated by intention-to-treat (ITT) and per-protocol (PP) analysis. | 3.5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with adverse effects as a measure of safety | The safety will be evaluated by counting the number of participant with adverse events. | 3.5 years | 
| Amount of unused medication post treatment as a measure of patient adherence. | The patient adherence will be evaluated by counting unused medication after the treatment. | 3.5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Helicobacter pylori, high dose dual therapy, bismuth-containing quadruple therapy, antibiotic resistance