Efficiency Study of Clarithromycin and Bismuth-containing Quadruple Therapy to Treat H.Pylori

Shanghai Jiao Tong University School of Medicine180 enrolled

Overview

The purpose of this study is to observe the efficacy of ten day triple therapy-based, bismuth-containing quadruple therapy for H.pylori treatment.

The success rate of currently recommended triple therapy with a proton pump inhibitor (PPI) plus amoxicillin and clarithromycin has fallen into the unacceptable range. The purpose of this study is to observe the efficacy of ten day triple therapy-based, bismuth-containing quadruple therapy for H.pylori treatment, while ten day triple therapy is used as control.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

180

Conditions

Functional Dyspepsia Peptic Ulcer Helicobacter Pylori

Interventions

EsomeprazoleDRUG

antisecretary drug of the quadruple therapy

AmoxicillinDRUG

antibiotic of the quadruple therapy

ClarithromycinDRUG

antibiotic of the quadruple therapy

Bismuth Potassium Citrate

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * patients who presented with upper gastrointestinal symptoms and endoscopically proven H.pylori-positive functional dyspepsia and scarred peptic ulcers Exclusion Criteria: * patients less than 18 years old, with history of H. pylori infection treatment, with previous gastric surgery, pregnancy, lactation, major systemic diseases, administration of antibiotics, bismuth, antisecretory drugs in the preceding 8 weeks, or allergy to any one of the given medication in the regimens.

Locations (1)

Renji Hospital

Shanghai, Shanghai Municipality, China

Outcomes

Primary Outcomes

Eradication rate of Helicobacter pylori

To calculate and compare the efficacy of 10 day and 14 day triple therapies with and without bismuth,to examine whether long duration and addition of bismuth affects the eradication.

Time frame: 2 months

Data from ClinicalTrials.gov

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