NCT05614934

Vonoprazan-based Therapy Versus Standard Regimen for Helicobacter Pylori Infection Management

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 132 (actual)
• Sponsor: Alexandria University · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

Appropriately, half of the global population is infected with H. pylori, and it is now recognized that it causes at least 95% of all gastric cancers. Currently, the main challenge in the field of H. pylori infection is the rapidly increasing antibiotic resistance worldwide, which is causing a decline in the effectiveness of currently available eradication regimens. The aim of the study is to assess the safety and efficacy of different H. pylori vonoprazan-based regimens compared to the commonly used standard triple therapy composed of Clarithromycin, Amoxicillin, and Proton pump inhibitor to eradicate H. pylori infection in treatment-naive patients through the determination of each regimen eradication rate and reported safety profile

Detailed description

1. Ethical committee approval is obtained from Ethics committee of Faculty of Medicine, Alexandria University. 2. All participants should agree to take part in this clinical study and will provide informed consent. 3. Patients with suspected H. pylori infection are recruited from Alexandria University out-patient clinics 4. Participants' demographic data, Full medical and medication history, and detailed clinical presentation is documented 5. Participants are tested for H. pylori infection using rapid H. pylori stool antigen test device 6. Negative subjects are excluded while positive patients are randomly allocated to 3 groups of different H. pylori regimens (Standard triple, Vonoprazan dual, and Vonoprazan triple) 7. Following up treatment side effects while taking the medications. 8. Assessing regimens effectiveness through patient retesting at least 1 month after treatment completion. 9. Assessing patient compliance to different regimens during the final visit. 10. Statistical tests appropriate to the study design will be conducted to evaluate the significance of the results. 11. Results, conclusion, discussion and recommendations will be given.

Conditions

• Helicobacter Pylori Infection

Interventions

Type	Name	Description
DRUG	standard Clarithromycin triple therapy	Oral administration of proton pump inhibitor standard or double dose twice daily, clarithromycin 500 mg twice daily and, Amoxicillin1g twice daily for 14 days
DRUG	Vonoprazan triple therapy	Oral administration of Vonoprazan 20mg twice daily, clarithromycin 500 mg twice daily, and, Amoxicillin1g twice daily for 14 days
DRUG	Vonoprazan dual therapy	Oral administration of Vonoprazan 20mg twice daily and, Amoxicillin1g three times daily for 14 days

Timeline

• Start date: 2022-06-11
• Primary completion: 2023-05-01
• Completion: 2023-05-15
• First posted: 2022-11-14
• Last updated: 2025-02-21

Locations

1 site across 1 country: Egypt