Helicobacter Pylori Infection
Conditions
Keywords
Helicobacter pylori, Bismuth quadruple therapy, Tailored therapy, Empiric therapy, clarithromycin susceptibility
Brief summary
With markedly increased antibiotic resistance and unsatisfactory efficacies of common empiric eradication regimens in the mainland of China, tailored therapy may be the best choice to achieve good efficacy. This study compared the eradication rates, safety, and compliance of antibiotic sensitivity-based tailored therapy compared with empiric bismuth quadruple therapy in the naive patients with Helicobacter pylori infection.
Interventions
DRUGEsomeprazole
proton pump inhibitor
DRUGBismuth Potassium Citrate
Gastric mucosal protective drug with anti-H. pylori effect
DRUGAmoxicillin
antibiotic for H. pylori eradication
DRUGClarithromycin
antibiotic for H. pylori eradication
DRUGMetronidazole
antibiotic for H. pylori eradication
DRUGLevofloxacin
antibiotic for H. pylori eradication
Sponsors
Shanghai Jiao Tong University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Helicobacter pylori eradication rate | Six weeks after completion of therapy | Six weeks after completion of therapy, H. pylori eradication was assessed by ¹³C-urea breath test. Eradication was defined as negative result from urea breath test (\<4‰) (4‰ as the cutoff value). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of adverse effects | within 7 days after completion of therapy | During the 14-day treatment period, the subjects kept a diary to score any possible side effects or discomforts. The subjects were asked to grade the severity of adverse events according to their influence on daily activities, experienced as mild (transient and well tolerated), moderate (causing discomfort and partially interfering with daily activities), or severe (causing considerable interference with daily activities). The side effect score recorded was based on the most severe event. |
| Compliance rate | within 7 days after completion of therapy | Compliance was defined as poor when they had taken less than 80% of the total medication. |
Other
| Measure | Time frame |
|---|---|
| Medical cost per patient of tailored or empiric therapy | two months after completion of therapy |
| Ratio of medical cost to H. pylori eradication rate of each therapy | two months after completion of therapy |
| Ratio of incremental medical cost to incremental H. pylori eradication rate of tailored compared with empiric therapy | two months after completion of therapy |
Countries
China
Outcome results
None listed