Helicobacter Pylori Infection
Conditions
Keywords
dual therapy, bismuth-containing quadruple therapy, Helicobacter Pylori
Brief summary
This study aims to evaluate the efficacy of dual therapy compared with bismuth-containing quadruple therapy as first-line treatment for Helicobacter Pylori eradication, as well as the safety and economic benefits.
Interventions
DRUGVonoprazan
Potassium-competitive acid blocker
DRUGRabeprazole
Proton pump inhibitor
DRUGAmoxicillin
Antibiotic for H. pylori eradication
DRUGClarithromycin
Antibiotic for H. pylori eradication
Gastric mucosal protective drug with anti-H. pylori effect
Sponsors
Second Affiliated Hospital, School of Medicine, Zhejiang University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. having H. pylori related chronic gastritis confirmed by ¹³C-urea breath test, ¹⁴C-urea breath test and/or biopsy； 2. underwent gastroscopy within 1 year before treatment, liver and renal function tests and electrocardiogram within 3 months before treatment； 3. with no historical treatment for helicobacter pylori infection.
Exclusion criteria
1. administration of antibiotics, bismuth in 4 weeks prior to inclusion or antacids including H2 receptor antagonist, proton pump inhibitor and potassium-competitive acid blocker in 2 weeks prior to inclusion 2. with previous esophageal or gastric surgery 3. with severe systemic diseases, major organ like heart, lung, brain diseases, liver or kidney insufficiency, malignant tumor or other diseases 4. allergy to any of the study drugs 5. participated in other research within 3 months，cannot express his/her own ideas correctly or cannot cooperate with the researcher
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Helicobacter pylori Eradication Rate | Six to eight weeks after completion of the medication | Helicobacter pylori Eradication will be determined by ¹³C-urea breath test six to eight weeks after completion of the medication. The eradication rates will be evaluated by intention-to-treat (ITT) and per-protocol (PP) analysis. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Adverse Drug Reaction(ADR) | Within 7 days after completion of therapy | Adverse drug reactions are classified into six types (with mnemonics): dose-related (Augmented), non-dose-related (Bizarre), dose-related and time-related (Chronic), time-related (Delayed), withdrawal (End of use), and failure of therapy (Failure). |
| 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
Contacts
Primary ContactQin Du, Master
Outcome results
None listed