Five Days Quadruple and Clarithromycin Containing Triple Therapy as Treatment for Helicobacter Pylori Eradication

The University of Hong Kong800 enrolled

Overview

The aim of this randomized trial is to compare the efficacy and tolerability of H. pylori eradication with a 5-day quadruple therapy versus a clarithromycin-containing triple therapy.

Eligible patients with H pylori infection were randomized to receive either five-day QUAD (esomeprazole 20mg b.d., bismuth subcitrate 120mg q.i.d., tetracycline 250mg q.i.d. and metronidazole 250mg q.i.d.) or EAC (esomeprazole 20mg b.d., amoxicillin 1g b.d. and clarithromycin 500mg b.d.). H. pylori status was rechecked by 13C urea breath test 8 weeks after treatment. Patients who failed their respective therapy were invited to undergo H. pylori susceptibility testing and crossover to receive the alternative regimen for the same duration.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

800

Conditions

Helicobacter Pylori Infection

Interventions

Quadruple therapyDRUG

First line: 5 days esomeprazole 20mg b.d., bismuth subcitrate 120mg q.i.d., tetracycline 250mg q.i.d. and metronidazole 250mg q.i.d. Cross over second line for those who failed first line: 7 days esomeprazole 20mg b.d., amoxicillin 1g b.d. and clarithromycin 500mg b.d

Triple therapyDRUG

First line: 7 days esomeprazole 20mg b.d., amoxicillin 1g b.d. and clarithromycin 500mg b.d Second line cross over if failed first line: 7 days quadruple therapy: esomeprazole 20mg b.d., bismuth subcitrate 120mg q.i.d., tetracycline 250mg q.i.d. and metronidazole 250mg q.i.d.)

Eligibility

Sex: ALLMin age: 21 Years

Medical Language ↔ Plain English

Inclusion Criteria: * patients with H. pylori infection * did not receive H. pylori eradication therapy before Exclusion Criteria: * patients who have received previous H. pylori eradication therapy * co-morbidity of liver cirrhosis * co-morbidity of renal failure * co-morbidity of alcoholism * co-morbidity of malignancy * received antibiotics, bismuth preparations, proton pump inhibitors or probiotic in the preceding three months * patients with known allergy to the medications used * patients with a history of previous gastrointestinal diseases or gastric surgery * pregnancy

Locations (1)

The University of Hong Kong, Queen Mary Hospital

Hong Kong SAR, Hong Kong

Outcomes

Primary Outcomes

H pylori eradication

Successful H pylori eradication documented by urea breath test after first and second line treatments. Cross over if patients failed first line treatment

Time frame: 8 weeks after treatment

Secondary Outcomes

Number of Participants with Adverse Events as a Measure of Safety and Tolerability

Assessed adverse effects and compliance by standard questionnaire upon 10 weeks outpatient follow-up

Time frame: 10 weeks outpatient follow-up

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.