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

Tanta University320 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

320

Conditions

Potassium-Competitive Acid Blocker Proton Pump Inhibitor Bismuth Based Quadruple Therapy

Interventions

Potassium-Competitive Acid BlockerDRUG

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

Proton Pump InhibitorDRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Helicobacter pylori eradication

Helicobacter pylori eradication rate will be recorded.

Time frame: 2 weeks after proton pump inhibitor

Secondary Outcomes

Adverse drug reactions

Adverse drug reactions will be recorded.

Time frame: 2 weeks after proton pump inhibitor

Patient adherence

Adherence will be assessed by asking patients to return used packaging and by questioning.

Time frame: 2 weeks after proton pump inhibitor

Degree of patient satisfaction

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)

Time frame: 2 weeks after proton pump inhibitor

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts