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

NCT07165444 | Recruiting

• 1 other identifier: 36264PR1285/7/25
• Study Type: interventional
• Target: 320
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Helicobacter pylori eradication

  Helicobacter pylori eradication rate will be recorded.

  2 weeks after proton pump inhibitor

Secondary Outcomes (3)

• Adverse drug reactions

  2 weeks after proton pump inhibitor

• Patient adherence

  2 weeks after proton pump inhibitor

• Degree of patient satisfaction

  2 weeks after proton pump inhibitor

Study Arms (2)

B-CAP group

EXPERIMENTAL

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

Drug: Potassium-Competitive Acid Blocker

PPI group

ACTIVE COMPARATOR

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

Drug: Proton Pump Inhibitor

Interventions

Potassium-Competitive Acid Blocker DRUG

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

B-CAP group

Proton Pump Inhibitor DRUG

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

PPI group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University

Tanta, El-Gharbia, 31527, Egypt

RECRUITING

MeSH Terms

Interventions

Proton Pump Inhibitors

Intervention Hierarchy (Ancestors)

Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses

Central Study Contacts

Mohamed G Flefel, MD

CONTACT

00201009156988; mohamed.galal@med.tanta.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Internal Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt.

Study Record Dates

• First Submitted: September 3, 2025
• First Posted: September 10, 2025
• Study Start: September 11, 2025
• Primary Completion: February 1, 2026
• Study Completion: February 1, 2026
• Last Updated: September 12, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)