Tailored Versus Empiric Therapy for Helicobacter Pylori Treatment

Shanghai Jiao Tong University School of Medicine382 enrolled

Overview

With markedly increased antibiotic resistance and unsatisfactory efficacies of common empiric eradication regimens in the mainland of China, tailored therapy may be the best choice to achieve good efficacy. This study compared the eradication rates, safety, and compliance of antibiotic sensitivity-based tailored therapy compared with empiric bismuth quadruple therapy in the naive patients with Helicobacter pylori infection.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

382

Conditions

Helicobacter Pylori Infection

Interventions

EsomeprazoleDRUG

proton pump inhibitor

Bismuth Potassium CitrateDRUG

Gastric mucosal protective drug with anti-H. pylori effect

AmoxicillinDRUG

antibiotic for H. pylori eradication

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Participants with non-ulcer functional dyspepsia or scarred peptic ulcer disease * Ability and willingness to participate in the study and to sign and give informed consent * confirmed H. pylori infection Exclusion Criteria: * Previous H. pylori eradication therapy * Less than 18 years old * With history of H. pylori infection treatment * 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 (5)

Ruijin Hospital, School of Medicine, Shanghai Jiao Tong University

Shanghai, Shanghai Municipality, China

Shanghai General Hospital, Shanghai First People's Hospital, Shanghai Jiao Tong University

Shanghai, Shanghai Municipality, China

Shanghai Tenth People's Hospital, Tongji University

Shanghai, Shanghai Municipality, China

Zhongshan Hospital,Fudan 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

During the 14-day treatment period, the subjects kept a diary to score any possible side effects or discomforts. 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). The side effect score recorded was based on the most severe event.

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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