Clarithromycin Triple Therapy Plus Bismuth for Helicobacter Pylori First-line Treatment

Shanghai Jiao Tong University School of Medicine66 enrolled

Overview

Standard triple therapy including a proton pump inhibitor (PPI) and clarithromycin with either amoxicillin or metronidazole are no longer recommended as empirical ﬁrst-line therapy to treat Helicobacter pylori infection because of high antibiotic resistance. It is unknown whether the addition of bismuth overcome antibiotic resistance. This study is designed to evaluate the efficacy and safety of the addition of bismuth to standard triple therapy for H. pylori first-line eradication.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Helicobacter Pylori Infection

Interventions

EsomeprazoleDRUG

Given 30 min before morning and evening meals

Bismuth Potassium CitrateDRUG

Given 30 min before morning and evening meals

ClarithromycinDRUG

Given 30 min after morning and evening meals

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 (1)

Renji Hospital, School of Medicine, Shanghai Jiao Tong University

Shanghai, Shanghai Municipality, China

Outcomes

Primary Outcomes

Helicobacter pylori eradication rate

Time frame: Six weeks after completion of therapy

Secondary Outcomes

Rate of adverse effects

Time frame: within 7 days after completion of therapy

Compliance rate

Time frame: within 7 days after completion of therapy

Data from ClinicalTrials.gov

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