Potassium-Competitive Acid Blocker Versus Proton Pump Inhibitor as A Part of Bismuth Based Quadruple Therapy for Treatment of Helicobacter Pylori Infection
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Potassium-Competitive Acid Blocker, Proton Pump Inhibitor.
- Who it may be relevant to
- Registry conditions: Potassium-Competitive Acid Blocker, Proton Pump Inhibitor, Bismuth Based Quadruple Therapy, Treatment. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official 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
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.
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.
Interventions
- 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.
Primary outcome measures
- Helicobacter pylori eradication [Time frame: 2 weeks after proton pump inhibitor]
Secondary outcome measures (3)
- Adverse drug reactions [Time frame: 2 weeks after proton pump inhibitor]
- Patient adherence [Time frame: 2 weeks after proton pump inhibitor]
- Degree of patient satisfaction [Time frame: 2 weeks after proton pump inhibitor]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- Tanta University — Tanta
Identifiers
NCT: NCT07165444 · 36264PR1285/7/25