Trials / Recruiting
RecruitingNCT07165444
Potassium-Competitive Acid Blocker Versus Proton Pump Inhibitor as A Part of Bismuth Based Quadruple Therapy for Treatment of Helicobacter Pylori Infection
Potassium-Competitive Acid Blocker Versus Proton Pump Inhibitor as A Part of Bismuth Based Quadruple Therapy for Treatment of Helicobacter Pylori Infection: A Randomized Controlled Trial
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 320 (estimated)
- Sponsor
- Tanta University · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This study aims to compare the eradication rate, safety, and patient adherence between potassium-competitive acid blockers (P-CABs) and proton pump inhibitor-based bismuth quadruple therapy in patients with Helicobacter pylori infection.
Detailed description
Helicobacter pylori (H. pylori) is a spiral-shaped, Gram-negative bacterium that colonizes the stomach lining and is considered one of the most prevalent chronic infections globally. Bismuth-based quadruple therapy (proton pump inhibitor, bismuth, metronidazole, and tetracycline) is considered an effective alternative in cases of antibiotic resistance. This regimen achieves high eradication rates, even in areas with dual clarithromycin and metronidazole resistance. Potassium-competitive acid blockers (P-CABs), such as vonoprazan, provide rapid, consistent, and strong acid suppression regardless of the CYP2C19 genotype.
Conditions
- Potassium-Competitive Acid Blocker
- Proton Pump Inhibitor
- Bismuth Based Quadruple Therapy
- Treatment
- Helicobacter Pylori Infection
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Potassium-Competitive Acid Blocker | Patients will a 10-day course of bismuth, metronidazole, tetracycline four times daily, and vonoprazan 20 mg twice daily. |
| DRUG | Proton Pump Inhibitor | Patients will receive a 10-day course of bismuth, metronidazole, tetracycline four times daily, and rabeprazole 20 mg twice daily. |
Timeline
- Start date
- 2025-09-11
- Primary completion
- 2026-02-01
- Completion
- 2026-02-01
- First posted
- 2025-09-10
- Last updated
- 2025-09-12
Locations
1 site across 1 country: Egypt
Source: ClinicalTrials.gov record NCT07165444. Inclusion in this directory is not an endorsement.