Helicobacter Pylori Infection
Conditions
Keywords
Vonoprazan, Standard Quadruple Therapy
Brief summary
The eradication rate of standard quadruple therapy has become less successful due to low compliance and high resistance to antibiotics. Therefore, it is necessary to develop new treatment strategies that increase the eradication rate and reduce adverse effects. The aim of this prospective study is to investigate the efficacy of Triple Therapy with Vonoprazan, Amoxicillin, and Bismuth for eradication of Hp, compared with standard quadruple therapy.
Detailed description
In China, the first-line therapy to treat Helicobacter pylori (Hp) consists of a bismuth-based proton pump inhibitor (PPI) and two antibiotics for 14 days.But, eradication has become less successful due to low compliance and high resistance to antibiotics. Therefore, it is necessary to develop new treatment strategies that increase the eradication rate and reduce adverse effects. Vonoprazan is a novel potassium-competitive acid blocker more effective in suppressing acid production than proton pump inhibitors (PPIs). Several studies previously suggested that vonoprazan containing antibiotic therapy was superior to other PPI-containing therapies for Hp. Most strains of Helicobacter pylori are sensitive to amoxicillin. Bismuth salts, a topical agent, which are available in our country, have a synergistic effect on antibiotics and decrease the bacterial load. Therefore, the investigators performed a prospective, multi-center, randomized trial, to investigate the efficacy of Triple Therapy with Vonoprazan, Amoxicillin, and Bismuth for eradication of Hp, compared with standard quadruple therapy.
Interventions
DRUGVonoprazan
20mg bid
DRUGAmoxicillin
0.75g tid
DRUGEsomeprazole
20mg bid
DRUGClarithromycin
0.5g bid
DRUGBismuth potassium citrate
0.22g bid
Sponsors
Huazhong University of Science and Technology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Helicobacter pylori infected patients comfirmed by 13C/14C UBT * age 18\ 65
Exclusion criteria
* prior Hp eradication therapy including amoxicillin and clarithromycin * previous gastric resection * allergic to the drugs used in this study * previous use of proton pump inhibitors, bismuth, H2 receptor antagonist or antibiotics, probiotics within 4 weeks of the study * Patients who were pregnant or lactating * Patients taking NSAIDs, alcoholic or with other serious disease (e.g. hepatopathy, heart disease, nephropathy#diabete mellitus, hypertension…) effect the evaluation of this study * Can't express the complaint correctly
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Helicobacter pylori eradication | 6 weeks after treatment initiation | to investigate the efficacy of Triple Therapy with Vonoprazan, Amoxicillin and Bismuth for eradication of Hp, compared with standard quadruple therapy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of adverse events | 2 weeks and 6 weeks after treatment initiation | to investigate the incidence of adverse events of Triple Therapy with Vonoprazan, Amoxicillin and Bismuth, compared with standard quadruple therapy. |
Countries
China
Contacts
Primary ContactBin Cheng, Doctor
Backup Contactsi xiong, Doctor
Outcome results
None listed