Helicobacter Pylori
Conditions
Keywords
Proton Pump Inhibitors
Brief summary
This study aims to compare the efficacy of the current standard first-line anti-helicobacter pylori regimen, extended proton pump inhibitor-based sequential therapy, with that of vonoprazan-based triple therapy, through a randomized controlled trial.
Detailed description
Helicobacter pylori infection is a well-established risk factor for peptic ulcer disease and gastric cancer. It's now a consensus of experts that H.pylori infection should be treated once it is recognized. Extended proton pump inhibitor (PPI)-based sequential therapy as one of the most commonly used first-line regimens provides a satisfactory eradication rate of 90.7% (95% CI, 87.4% - 94.0%). Nevertheless, its complexity of the "sequential" usage is sometimes confusing to the patients and may lead to treatment failure. The emerging new regimen - vonoprazan-based triple therapy, on the other hand, is another appealing choice with simplicity, short treatment duration, and low pill burden. However, there's still no evidence regarding the use of vonoprazan-based triple therapy with high-dose amoxicillin (1000mg twice daily) as the first-line regimen. This study aimed to compare the efficacy of the current standard first-line regimen, sequential therapy, with that of vonoprazan-based triple therapy with high-dose Amoxicillin.
Interventions
DRUGVonoprazan-based triple therapy
vonoprazan 20mg+amoxicillin 1000 mg + clarithromycin 500 mg twice daily for seven days
DRUGExtended sequential therapy
Lansoprazole 30mg + amoxicillin 1000mg twice daily for 7 days, followed by lansoprazole 30mg + clarithromycin 500mg + metronidazole 500mg twice daily for 7 days
Sponsors
Fu Jen Catholic University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with H.pylori infection who was over 20 years old and agree to participate in the trial will be recruited.
Exclusion criteria
* Who had received helicobacter pylori eradication before * Who are known to be allergic to any drug used in this trial * Pregnant women * Who are refuse to participate in the trial for any reason
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Eradication rate of helicobacter pylori | Assessed at least 6 weeks after the therapy | Assessed by urea breath test |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse effects of the drugs | After patients completed the therapy (For VAC-7 group: 1 week after the therapy; For S-14 group: 2 weeks after the therapy) | Self-reported adverse effects by patients through a questionnaire. |
| Compliance | After patients completed the therapy ((For VAC-7 group: 1 week after the therapy; For S-14 group: 2 weeks after the therapy) | Self-reported compliance by patients through a questionnaire. |
Countries
Taiwan
Contacts
STUDY_CHAIRYu-tse Chiu, MD
Fu Jen Catholic University Hospital
Outcome results
None listed