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

NCT ID: NCT07165444

Last Updated: 2025-09-12

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 320 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-11
• Study Completion Date: 2026-02-01

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.

Conditions

Potassium-Competitive Acid Blocker; Proton Pump Inhibitor; Bismuth Based Quadruple Therapy; Treatment; Helicobacter Pylori Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

B-CAP group

Patients will a 10-day course of bismuth, metronidazole, tetracycline four times daily, and vonoprazan 20 mg twice daily.

Group Type: EXPERIMENTAL

Potassium-Competitive Acid Blocker

Intervention Type: DRUG

Patients will a 10-day course of bismuth, metronidazole, tetracycline four times daily, and vonoprazan 20 mg twice daily.

PPI group

Patients will receive a 10-day course of bismuth, metronidazole, tetracycline four times daily, and rabeprazole 20 mg twice daily.

Group Type: ACTIVE_COMPARATOR

Proton Pump Inhibitor

Intervention Type: DRUG

Patients will receive a 10-day course of bismuth, metronidazole, tetracycline four times daily, and rabeprazole 20 mg twice daily.

Interventions

Potassium-Competitive Acid Blocker

Patients will a 10-day course of bismuth, metronidazole, tetracycline four times daily, and vonoprazan 20 mg twice daily.

Intervention Type: DRUG

Proton Pump Inhibitor

Patients will receive a 10-day course of bismuth, metronidazole, tetracycline four times daily, and rabeprazole 20 mg twice daily.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tanta University

OTHER

Sponsor Role: lead

Responsible Party

Mohamed Galal Flefel

Lecturer of Internal Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Tanta University

Tanta, El-Gharbia, Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Mohamed G Flefel, MD

Role: CONTACT

mohamed.galal@med.tanta.edu.eg

00201009156988

Facility Contacts

Mohamed G Flefel, MD

Role: primary

mohamed.galal@med.tanta.edu.eg

00201009156988

Other Identifiers

36264PR1285/7/25

Identifier Type: -

Identifier Source: org_study_id