Helicobacter Pylori Infection
Conditions
Keywords
Helicobacter pylori, Therapy
Brief summary
Dual therapy for Helicobacter Pylori including a proton pump inhibitor (PPI) and amoxicillin. Amoxicillin has low resistance rate as well as low percentage of side effects. No trial has examined the the efficacy of high dose of dual therapy plus bismuth for H. pylori treatment.This study is designed to evaluate the efficacy and safety of the addition of bismuth to high dose of dual therapy for H. pylori eradication.
Interventions
DRUGEsomeprazole
Proton pump inhibitor
DRUGAmoxicillin
Antibiotic for H. pylori eradication
DRUGBismuth Potassium Citrate
Gastric mucosal protective drug with anti-H. pylori effect
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
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. |
Countries
China
Outcome results
None listed