Potassium-Competitive Acid Blocker Versus Proton Pump Inhibitor as A Part of Bismuth Based Quadruple Therapy for Treatment of Helicobacter Pylori Infection

Not Applicable

Recruiting

• Conditions: Potassium-Competitive Acid Blocker; Proton Pump Inhibitor; Bismuth Based Quadruple Therapy; Treatment; Helicobacter Pylori Infection
• Interventions: Drug: Potassium-Competitive Acid Blocker; Drug: Proton Pump Inhibitor

• Registration Number: NCT07165444
• Lead Sponsor: Tanta University

Brief 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.

Study Timeline

• Status Verified: 2025-09
• Study First Submitted: 2025-09-03
• Study First Submitted QC: 2025-09-03
• Study First Posted: 2025-09-10
• Study Start: 2025-09-11
• Last Update Submitted: 2025-09-11
• Last Update Posted: 2025-09-12
• Primary Completion: 2026-02-01
• Study Completion: 2026-02-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 320

Inclusion Criteria

• Adults aged ≥18 years.
• Both sexes.
• Confirmed Helicobacter pylori infection by stool antigen (3rd-gen ELISA) or urea breath test (UBT).
• No prior eradication therapy.

Exclusion Criteria

• Prior Helicobacter pylori treatment.
• Use of antibiotics, proton pump inhibitor, or bismuth in the prior 4 weeks.
• Gastric surgery history.
• Major organ failure.
• Pregnancy or lactation.
• Known allergy to study drugs.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
B-CAP group	Potassium-Competitive Acid Blocker	Patients will a 10-day course of bismuth, metronidazole, tetracycline four times daily, and vonoprazan 20 mg twice daily.
PPI group	Proton Pump Inhibitor	Patients will receive a 10-day course of bismuth, metronidazole, tetracycline four times daily, and rabeprazole 20 mg twice daily.

Primary Outcome Measures

Name	Time	Method
Helicobacter pylori eradication	2 weeks after proton pump inhibitor	Helicobacter pylori eradication rate will be recorded.

Secondary Outcome Measures

Name	Time	Method
Adverse drug reactions	2 weeks after proton pump inhibitor	Adverse drug reactions will be recorded.
Patient adherence	2 weeks after proton pump inhibitor	Adherence will be assessed by asking patients to return used packaging and by questioning.
Degree of patient satisfaction	2 weeks after proton pump inhibitor	Degree of patient satisfaction will be assessed on a 5-point Likert scale patient satisfaction (1, extremely dissatisfied; 2, unsatisfied; 3, neutral; 4, satisfied; 5, extremely satisfied)

Trial Locations

Locations (1)

Tanta University; 🇪🇬 Tanta, El-Gharbia, Egypt