Helicobacter Pylori Infection
Conditions
Keywords
Helicobacter pylori, Tailored therapy, Penicillin allergy, Antimicrobial susceptibility testing
Brief summary
Increasing drug resistance presents a significant challenge to the efficacies of common empiric eradication regimens for Helicobacter pylori treatment in the mainland of China. Tailored therapy may be the best choice to achieve good efficacy, especially in patients with penicillin allergy. Few studies had evaluated the patients with penicillin allergy.This study is designed to evaluate the efficacy and safety of antibiotic sensitivity-based tailored therapy for Helicobacter pylori treatment in the patients with penicillin allergy.
Interventions
DRUGMetronidazole
antibiotic for H. pylori eradication
DRUGClarithromycin
antibiotic for H. pylori eradication
DRUGEsomeprazole
Proton pump inhibitor
DRUGBismuth Potassium Citrate
Gastric mucosal protective drug with anti-H. pylori effect
DRUGLevofloxacin
antibiotic for H. pylori eradication
DRUGTetracycline
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
Intervention model description
After antimicrobial susceptibility testing of Helicobacter pylori from biopsy samples, according to antibiotic resistance pattern of each one, give esomeprazole 20mg bid, bismuth potassium citrate 600mg bid and two sensitive ones of clarithromycin, metronidazole,levofloxacin and tetracycline.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Participants with penicillin allergy who have 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
* Patients without penicillin allergy * 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. |
Countries
China
Outcome results
None listed