H Pylori
Conditions
Keywords
omeprazole, vonoprazon, proton pump inhibitors
Brief summary
Current studies have primarily focused on comparing the advantages and disadvantages of P-CAB and PPI drugs, with little comparison between different P-CAB drugs or between regimens with varying drug combinations and treatment durations. This study aims to evaluate the clinical effectiveness of vonoprazan-based H. pylori eradication therapy and compare it to that of conventional PPI based therapy in clinical practice.
Detailed description
Currently, there are numerous H. pylori eradication regimens, but opinions vary regarding the effectiveness of those based on P-CAB or PPI. Zhang et al. 4 concluded that the P-CAB-based triple regimen was superior to the PPI-based regimen, whereas Du et al.5 suggested that a vonoprazan and amoxicillin duo regimen may be the preferred first-line option for H. pylori eradication in clinical practice. However, due to limited evidence, the efficacy of various H. pylori eradication regimens using tegoprazan or vonoprazan could not be compared. Current studies have primarily focused on comparing the advantages and disadvantages of P-CAB and PPI drugs, with little comparison between different P-CAB drugs or between regimens with varying drug combinations and treatment durations. This study aims to evaluate the clinical effectiveness of vonoprazan-based H. pylori eradication therapy and compare it to that of conventional PPI based therapy in clinical practice. Objective: To compare the efficacy of vonoprazan-based H. pylori eradication therapy with conventional proton pump inhibitors based therapy.
Interventions
Clarithromycin 500 mg orally twice daily for 14 days
DRUGAmoxicillin 1 g
Omeprazole 40 mg orally twice daily for 14 days, then 40 mg once daily for 4 weeks
DRUGOmeprazole 40 mg
Omeprazole 40 mg orally twice daily for 14 days, then 40 mg once daily for 4 weeks
DRUGVonoprazan 20 mg
Vonoprazan 20 mg orally twice daily for 14 days, then 20 mg once daily for 4 weeks
DRUGLevofloxacin 500 mg
Levofloxacin 500 mg orally once daily for 14 days
Sponsors
Rehman Medical Institute - RMI
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* All patients who tested positive on stool antigen
Exclusion criteria
* patients under 12 years old. * Patients who have penicillin allergy. * Patients who have underlying dysrhythmia forbidding the use of macrolide -. Patient who have hypersensitivity to any of these antibiotics or proton pump inhibitors.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| H. pylori Eradication Rate | 4-6 weeks after completion of therapy | Proportion of participants with successful eradication of Helicobacter pylori infection, confirmed by a negative stool antigen test. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Adverse Events | During the 6-week treatment and follow-up period | Number and type of treatment-related adverse effects (e.g., nausea, diarrhea, headache, abdominal discomfort) reported by participants during or after therapy |
Countries
Pakistan
Contacts
Primary ContactTaimur khan, FCPS
Backup ContactNaseer Ahmed, Associate professor
Outcome results
None listed