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

Helicobacter Pylori Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05614934
• Other study ID #: 0107175
• Status: Recruiting
• Phase: Phase 4
• Start date: June 11, 2022
• Est. completion date: March 15, 2023

Study information

• Verified date: November 2022
• Source: Alexandria University
• Contact: Yumna M Shekeban, BSc
• Phone: 01289990938
• Email: Yumna.shekeban[@]alexu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 81
• Est. completion date: March 15, 2023
• Est. primary completion date: February 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Helicobacter Infections
• Helicobacter Pylori Infection
• Infections

Intervention

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
• 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

Locations

Country	Name	City	State
Egypt	Alexandria University outpatient clinics	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
Alexandria University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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