High Dose of Dual Therapy Plus Metronidazole for Helicobacter Pylori RescueTreatment

Shanghai Jiao Tong University School of Medicine306 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

306

Conditions

Helicobacter Pylori Infection

Interventions

EsomeprazoleDRUG

Proton pump inhibitor

AmoxicillinDRUG

Antibiotic for H. pylori eradication

MetronidazoleDRUG

Antibiotic for H. pylori eradication

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Renji Hospital, School of Medicine, Shanghai Jiao Tong University

Shanghai, Shanghai Municipality, China

Outcomes

Primary Outcomes

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)

Time frame: Six weeks after completion of therapy

Secondary Outcomes

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)

Time frame: 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

Time frame: Within 7 days after completion of therapy

Data from ClinicalTrials.gov

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