Helicobacter Infection
Conditions
Keywords
Helicobacter pylori, Bismuth, Salvage treatment, Metronidazole
Brief summary
At present, triple therapy are recommended by various guidelines for the treatment of Helicobacter pylori (H. pylori) infection. Recent studies have shown worldwide high treatment failure rates with one week first line clarithromycin based triple therapy necessitating salvage strategy to eradicate H. pylori in primary treatment failure. However, the exact duration of bismuth based second line treatment is not determined. Therefore, the investigators performed this study to evaluate the eradication rate of 1 or 2-week quadruple regimen as a second-line therapy.
Interventions
DRUGpantoprazole
pantoprazole 40mg bid
DRUGbismuth
bismuth 300mg qid
DRUGmetronidazole
metronidazole 500mg tid
DRUGtetracycline
tetracycline 500mg qid
Sponsors
Inje University
Pacific Pharmaceuticals
Asan Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* H. pylori infection * Aged between 18-80 years * Are willing to received eradication therapy for H. pylori
Exclusion criteria
* Children and teenagers aged less than 18 years or over 80 years * Previous eradication therapy for H. pylori * History of gastrectomy * Previous allergic reaction to antibiotics * Use of prompt pump inhibitors and antibiotics in the recent 4 weeks * Active upper GI bleeding in the recent 1 week * Contraindication to treatment drugs * Pregnant or lactating women * Severe concurrent disease or malignancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Whether the two week group yield a higher eradication rate comparing to the one week group. | At least four week after completion of treatment |
Secondary
| Measure | Time frame |
|---|---|
| side effect | four weeks after completion of medication |
Countries
South Korea
Outcome results
None listed