Tailored Therapy for Helicobacter Pylori Rescue Treatment

Shanghai Jiao Tong University School of Medicine200 enrolled

Overview

With increasing antibiotic resistance and unsatisfactory results of empiric eradication regimens, tailored therapy may be the best choice to achieve high efficacy for rescue treatment. This study aimed to evaluate the eradication rates, safety, and compliance of antimicrobial susceptibility-based tailored therapy for rescue treatment in patients with Helicobacter pylori infection.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

200

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 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Participants with non-ulcer functional dyspepsia or scarred peptic ulcer disease * Previous failures of H. pylori eradication therapy and need rescue therapy * Ability and willingness to participate in the study and to sign and give informed consent * Confirmed H. pylori infection Exclusion Criteria: * Less than 18 years old * 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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