Health TrialsbyHealthPanel

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

ConditionsPotassium-Competitive Acid BlockerProton Pump InhibitorBismuth Based Quadruple TherapyTreatmentHelicobacter Pylori Infection
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorTanta University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Prior Helicobacter pylori treatment.

Use of antibiotics, proton pump inhibitor, or bismuth in the prior 4 weeks.

Gastric surgery history.

Major organ failure.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

320 Participants
are divided into 2 treatment groups
Group A: B-CAP groupExperimental treatment 1 intervention
Group B: PPI groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Helicobacter pylori eradication

Helicobacter pylori eradication rate will be recorded.

Time frame
2 weeks after proton pump inhibitor

Secondary outcomes

1

Adverse drug reactions

Adverse drug reactions will be recorded.

Time frame
2 weeks after proton pump inhibitor
2

Patient adherence

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

Time frame
2 weeks after proton pump inhibitor
3

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Tanta University

Lead sponsor

Source ClinicalTrials.gov
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