Comparison of Omeprazole vs Vonoprazon in Treatment of H Pylori Infection
- Conditions
- H Pylori
- Interventions
- Registration Number
- NCT07040839
- Lead Sponsor
- Rehman Medical Institute - RMI
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 128
- All patients who tested positive on stool antigen
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description First-Line Therapy with Omeprazole Clarithromycin 500 mg - First-Line Therapy with Omeprazole Amoxicillin 1 g - First-Line Therapy with Omeprazole Omeprazole 40 mg - First-Line Therapy with Vonoprazan Clarithromycin 500 mg - First-Line Therapy with Vonoprazan Amoxicillin 1 g - First-Line Therapy with Vonoprazan Vonoprazan 20 mg - Second-Line Therapy with Omeprazole Levofloxacin 500 mg - Second-Line Therapy with Omeprazole Amoxicillin 1 g - Second-Line Therapy with Omeprazole Omeprazole 40 mg - Second-Line Therapy with Vonoprazan Levofloxacin 500 mg Participants receiving second-line therapy (levofloxacin + amoxicillin) with vonoprazan as the acid suppressant. Second-Line Therapy with Vonoprazan Amoxicillin 1 g Participants receiving second-line therapy (levofloxacin + amoxicillin) with vonoprazan as the acid suppressant. Second-Line Therapy with Vonoprazan Vonoprazan 20 mg Participants receiving second-line therapy (levofloxacin + amoxicillin) with vonoprazan as the acid suppressant.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
Related Research Topics
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Trial Locations
- Locations (1)
Rehman Medical Institue
🇵🇰Peshawar, K, Pakistan
Rehman Medical Institue🇵🇰Peshawar, K, Pakistan