Helicobacter Pylori Infection
Conditions
Brief summary
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.
Detailed description
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.
Interventions
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
DRUGTriple therapy
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.)
Sponsors
The University of Hong Kong
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| H pylori eradication | 8 weeks after treatment | Successful H pylori eradication documented by urea breath test after first and second line treatments. Cross over if patients failed first line treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with Adverse Events as a Measure of Safety and Tolerability | 10 weeks outpatient follow-up | Assessed adverse effects and compliance by standard questionnaire upon 10 weeks outpatient follow-up |
Countries
Hong Kong
Outcome results
None listed