Vonoprazan-based Therapy Versus Standard Regimen for Helicobacter Pylori Infection Management

Appropriately, half of the global population is infected with H. pylori, and it is now recognized that it causes at least 95% of all gastric cancers. Currently, the main challenge in the field of H. pylori infection is the rapidly increasing antibiotic resistance worldwide, which is causing a decline in the effectiveness of currently available eradication regimens.

The aim of the study is to assess the safety and efficacy of different H. pylori vonoprazan-based regimens compared to the commonly used standard triple therapy composed of Clarithromycin, Amoxicillin, and Proton pump inhibitor to eradicate H. pylori infection in treatment-naive patients through the determination of each regimen eradication rate and reported safety profile

Study Overview

• Status: Completed
• Conditions: Helicobacter Pylori Infection
• Intervention / Treatment: Drug: standard Clarithromycin triple therapy; Drug: Vonoprazan triple therapy; Drug: Vonoprazan dual therapy

Detailed Description

1. Ethical committee approval is obtained from Ethics committee of Faculty of Medicine, Alexandria University.
2. All participants should agree to take part in this clinical study and will provide informed consent.
3. Patients with suspected H. pylori infection are recruited from Alexandria University out-patient clinics
4. Participants' demographic data, Full medical and medication history, and detailed clinical presentation is documented
5. Participants are tested for H. pylori infection using rapid H. pylori stool antigen test device
6. Negative subjects are excluded while positive patients are randomly allocated to 3 groups of different H. pylori regimens (Standard triple, Vonoprazan dual, and Vonoprazan triple)
7. Following up treatment side effects while taking the medications.
8. Assessing regimens effectiveness through patient retesting at least 1 month after treatment completion.
9. Assessing patient compliance to different regimens during the final visit.
10. Statistical tests appropriate to the study design will be conducted to evaluate the significance of the results.
11. Results, conclusion, discussion and recommendations will be given.

• Study Type: Interventional
• Enrollment (Actual): 132
• Phase: Phase 4

Contacts and Locations

Study Locations

• Egypt
  • Alexandria, Egypt
    • Alexandria University outpatient clinics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients with positive stool antigen test result for H. pylori
• Patients recently diagnosed with H. pylori infection and did not receive any treatment

Exclusion Criteria:

• Patients sensitive to any of the regimens' components
• Patients who had received a previous eradication therapy and still show positive test results
• Recent use of antimicrobial agents, proton pump inhibitors, and H2 receptor blockers within 1 month
• Patients with gastric malignancy or who underwent previous gastric surgery
• Pregnancy and lactation
• Patients with major concomitant diseases, including psychic disorders

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: S3; Standard clarithromycin triple	Drug: standard Clarithromycin triple therapy; Oral administration of proton pump inhibitor standard or double dose twice daily, clarithromycin 500 mg twice daily and, Amoxicillin1g twice daily for 14 days
Experimental: V3; Vonoprazan triple	Drug: Vonoprazan triple therapy; Oral administration of Vonoprazan 20mg twice daily, clarithromycin 500 mg twice daily, and, Amoxicillin1g twice daily for 14 days
Experimental: V2; Vonoprazan dual	Drug: Vonoprazan dual therapy; Oral administration of Vonoprazan 20mg twice daily and, Amoxicillin1g three times daily for 14 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Determination of the eradication rates for each regimen	Percentage eradication in each group is calculated by intention-to-treat analysis or per-protocol analysis.	1.5 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Determination of number of compliant participants to each regimen	Adherence to therapies is determined through pill count in medication boxes In addition to reviewing a daily medication schedule filled by the participant.	1.5 month
Determination of number of participants with treatment related adverse events	Patients will be contacted on a regular basis to monitor any reported adverse events	2 weeks

Collaborators and Investigators

• Sponsor: Alexandria University

Study record dates

Study Major Dates

• Study Start (Actual): June 11, 2022
• Primary Completion (Actual): May 1, 2023
• Study Completion (Actual): May 15, 2023

Study Registration Dates

• First Submitted: November 7, 2022
• First Submitted That Met QC Criteria: November 7, 2022
• First Posted (Actual): November 14, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 19, 2025
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Helicobacter Pylori; vonoprazan; standard triple therapy
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Negative Bacterial Infections; Infections; Communicable Diseases; Helicobacter Infections; Anti-Bacterial Agents; Anti-Infective Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Protein Synthesis Inhibitors; Cytochrome P-450 CYP3A Inhibitors; Clarithromycin
• Other Study ID Numbers: 0107175

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No