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NCT Number: NCT07165444

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tanta University

Tanta, El-Gharbia, 31527, Egypt

Location status: Recruiting

Location contact

Ahmed F Selim, MD

PRINCIPAL_INVESTIGATOR

Ashraf A Aboismail, MD

PRINCIPAL_INVESTIGATOR

Mohamed G Flefel, MD

CONTACT

[email protected]

00201009156988

Nashwa S Abdeen, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Potassium-Competitive Acid Blocker

Drug

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

Proton Pump Inhibitor

Drug

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

Primary outcomes

  1. Helicobacter pylori eradication

    Time frame: 2 weeks after proton pump inhibitor

    Helicobacter pylori eradication rate will be recorded.

Secondary outcomes

  1. Adverse drug reactions

    Time frame: 2 weeks after proton pump inhibitor

    Adverse drug reactions will be recorded.

  2. Patient adherence

    Time frame: 2 weeks after proton pump inhibitor

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

  3. Degree of patient satisfaction

    Time frame: 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Mohamed G Flefel, MD

CONTACT

[email protected]

00201009156988

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 10, 2025
Registry last updated
Sep 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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