Helicobacter Pylori Infection
Conditions
Brief summary
Dual therapy containing high dose of proton pump inhibitor (PPI) and amoxicillin had showed excellent eradication results with Helicobacter pylori first-line treatment. However, no study has examined the the efficacy of high dose of dual therapy or dual therapy plus metronidazole for H. pylori rescue treatment.This study is designed to evaluate the efficacy and safety of the addition of metronidazole to high dose of dual therapy for H. pylori rescue treatment.
Interventions
DRUGEsomeprazole
Proton pump inhibitor
DRUGAmoxicillin
Antibiotic for H. pylori eradication
DRUGMetronidazole
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 80 Years
Healthy volunteers
No
Inclusion criteria
* Participants with non-ulcer functional dyspepsia or peptic ulcer disease * Ability and willingness to participate in the study and to sign and give informed consent * Confirmed H. pylori infection and with previous treatment failure
Exclusion criteria
* Less than 18 years old or older than 80 years * 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