Helicobacter Pylori Infection
Conditions
Keywords
Helicobacter pylori, Rescue therapy, Tailored therapy, Antimicrobial susceptibility testing
Brief summary
With increasing antibiotic resistance and unsatisfactory results of empiric eradication regimens, tailored therapy may be the best choice to achieve high efficacy for rescue treatment. This study aimed to evaluate the eradication rates, safety, and compliance of antimicrobial susceptibility-based tailored therapy for rescue treatment in 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
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Participants with non-ulcer functional dyspepsia or scarred peptic ulcer disease * Previous failures of H. pylori eradication therapy and need rescue therapy * Ability and willingness to participate in the study and to sign and give informed consent * Confirmed H. pylori infection
Exclusion criteria
* Less than 18 years old * 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 | 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). |
| 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 therapy | Two months after completion of therapy |
Countries
China
Outcome results
None listed