High Dose of Dual Therapy Plus Metronidazole for Helicobacter Pylori RescueTreatment

Study Overview
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Brief Summary
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Dual therapy containing high dose of proton pump inhibitor (PPI) and amoxicillin had showed excellent eradication results with Helicobacter pylori first-line treatment. However, no study has examined the the efficacy of high dose of dual therapy or dual therapy plus metronidazole for H. pylori rescue treatment.This study is designed to evaluate the efficacy and safety of the addition of metronidazole to high dose of dual therapy for H. pylori rescue treatment.

Official Title
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Efficacy of High Dose of Dual Therapy Plus Metronidazole for Helicobacter Pylori Rescue Treatment: A Randomized Clinical Trial

Conditions
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Helicobacter Pylori Infection

Intervention / Treatment
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* Drug: Esomeprazole
* Drug: Amoxicillin
* Drug: Metronidazole


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants with non-ulcer functional dyspepsia or peptic ulcer disease Ability and willingness to participate in the study and to sign and give informed consent Confirmed H. pylori infection and with previous treatment failure Exclusion Criteria: Less than 18 years old or older than 80 years 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- |
| Active Comparator: Dual therapy<br>Esomeprazole 40mg bid and Amoxicillin 1.0g tid for 14 days | Drug: Esomeprazole<br>* Proton pump inhibitor<br>Drug: Amoxicillin<br>* Antibiotic for H. pylori eradication<br>|
| Experimental: Metronidazole plus dual therapy<br>Esomeprazole 40mg bid, Amoxicillin 1.0g tid and Metronidazole 0.4g tid for 14 days | Drug: Esomeprazole<br>* Proton pump inhibitor<br>Drug: Amoxicillin<br>* Antibiotic for H. pylori eradication<br>Drug: Metronidazole<br>* Antibiotic for H. pylori eradication<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Helicobacter pylori eradication rate | 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) | Six weeks after completion of therapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of adverse effects | 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) | Within 7 days after completion of therapy | 
| Compliance rate | Compliance was defined as poor when they had taken less than 80% of the total medication | Within 7 days after completion of therapy |