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Comparison of Omeprazole vs Vonoprazon in Treatment of H Pylori Infection

Not Applicable
Not yet recruiting
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
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
First-Line Therapy with OmeprazoleClarithromycin 500 mg-
First-Line Therapy with OmeprazoleAmoxicillin 1 g-
First-Line Therapy with OmeprazoleOmeprazole 40 mg-
First-Line Therapy with VonoprazanClarithromycin 500 mg-
First-Line Therapy with VonoprazanAmoxicillin 1 g-
First-Line Therapy with VonoprazanVonoprazan 20 mg-
Second-Line Therapy with OmeprazoleLevofloxacin 500 mg-
Second-Line Therapy with OmeprazoleAmoxicillin 1 g-
Second-Line Therapy with OmeprazoleOmeprazole 40 mg-
Second-Line Therapy with VonoprazanLevofloxacin 500 mgParticipants receiving second-line therapy (levofloxacin + amoxicillin) with vonoprazan as the acid suppressant.
Second-Line Therapy with VonoprazanAmoxicillin 1 gParticipants receiving second-line therapy (levofloxacin + amoxicillin) with vonoprazan as the acid suppressant.
Second-Line Therapy with VonoprazanVonoprazan 20 mgParticipants receiving second-line therapy (levofloxacin + amoxicillin) with vonoprazan as the acid suppressant.
Primary Outcome Measures
NameTimeMethod
H. pylori Eradication Rate4-6 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
NameTimeMethod
Incidence of Adverse EventsDuring 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

Trial Locations

Locations (1)

Rehman Medical Institue

🇵🇰

Peshawar, K, Pakistan

Rehman Medical Institue
🇵🇰Peshawar, K, Pakistan

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