Bismuth Based Quadruple Therapy, Helicobacter Pylori Infection, Potassium-Competitive Acid Blocker, Proton Pump Inhibitor, Treatment
Conditions
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.
Interventions
DRUGPotassium-Competitive Acid Blocker
Patients will a 10-day course of bismuth, metronidazole, tetracycline four times daily, and vonoprazan 20 mg twice daily.
DRUGProton Pump Inhibitor
Patients will receive a 10-day course of bismuth, metronidazole, tetracycline four times daily, and rabeprazole 20 mg twice daily.
Sponsors
Tanta University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Helicobacter pylori eradication | 2 weeks after proton pump inhibitor | Helicobacter pylori eradication rate will be recorded. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Countries
Egypt
Contacts
Primary ContactMohamed G Flefel, MD
Outcome results
None listed