Vonoprazan-based Therapy Versus Standard Regimen for Helicobacter Pylori Infection Management
NCT ID: NCT05614934
Last Updated: 2025-02-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
132 participants
INTERVENTIONAL
2022-06-11
2023-05-15
Brief Summary
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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
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Detailed Description
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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.
Conditions
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Study Design
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NA
PARALLEL
TREATMENT
NONE
Study Groups
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S3
Standard clarithromycin triple
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
V3
Vonoprazan triple
Vonoprazan triple therapy
Oral administration of Vonoprazan 20mg twice daily, clarithromycin 500 mg twice daily, and, Amoxicillin1g twice daily for 14 days
V2
Vonoprazan dual
Vonoprazan dual therapy
Oral administration of Vonoprazan 20mg twice daily and, Amoxicillin1g three times daily for 14 days
Interventions
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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
Vonoprazan triple therapy
Oral administration of Vonoprazan 20mg twice daily, clarithromycin 500 mg twice daily, and, Amoxicillin1g twice daily for 14 days
Vonoprazan dual therapy
Oral administration of Vonoprazan 20mg twice daily and, Amoxicillin1g three times daily for 14 days
Eligibility Criteria
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Inclusion Criteria
* Patients recently diagnosed with H. pylori infection and did not receive any treatment
Exclusion Criteria
* 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
ALL
No
Sponsors
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Alexandria University
OTHER
Responsible Party
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Yumna Mohamed Shekeban
Teaching Assistant at clinical pharmacy and pharmacy practice department, faculty of pharmacy Alexandria University
Locations
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Alexandria University outpatient clinics
Alexandria, , Egypt
Countries
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References
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Shekeban YM, Hamdy NA, Header DA, Ahmed SM, Helmy MM. Vonoprazan-based therapy versus standard regimen for Helicobacter pylori infection management in Egypt: an open-label randomized controlled trial. Sci Rep. 2025 May 8;15(1):15989. doi: 10.1038/s41598-025-98606-8.
Other Identifiers
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0107175
Identifier Type: -
Identifier Source: org_study_id
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