Rescue Therapy for Helicobacter Pylori Eradication Treatment

Shanghai Jiao Tong University School of Medicine368 enrolled

Overview

Current guidelines have recommended classical bismuth-containing quadruple therapy including proton-pump inhibitor, bismuth, tetracycline, metronidazole as the empirical rescue therapy. However, tetracycline is clinically unavailable in China and the high frequency of adverse events of bismuth quadruple therapy often result in poor compliance, which limited the applicability of this recommendation. This study aimed to compare the efficacy and tolerability of a 14-day bismuth-containing quadruple rescue therapy in which tetracycline was replaced by minocycline.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

368

Conditions

Helicobacter Pylori Infection

Interventions

EsomeprazoleDRUG

Proton pump inhibitor

Bismuth Potassium CitrateDRUG

Gastric mucosal protective drug with anti-H. pylori effect

Tetracycline,MetronidazoleDRUG

Antibiotics for H. pylori eradication

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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: * subjects naive to H. pylori treatment, * under 18 or over 80 years old * history of gastrectomy * pregnant or lactating women * severe systemic diseases or malignancy * administration of antibiotics, bismuth, antisecretory drugs, or Chinese herb medicine in the preceding 8 weeks * contraindications to the study drugs

Locations (3)

Shanghai East Hospital, Tongji University School of Medicine

Shanghai, Shanghai Municipality, China

Renji Hospital, School of Medicine, Shanghai Jiao Tong University

Shanghai, Shanghai Municipality, China

The Second Affiliated Hospital of Zhejiang University school of Medicine

Hangzhou, Zhejiang, 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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