Potassium Copetitive Acid Blockers Efficacy in H.Pylori Eradication

Phase 3

Completed

• Conditions: Helicobacter Pylori Eradication
• Interventions: Drug: Vonoprazan

• Registration Number: NCT06101420
• Lead Sponsor: Ain Shams University

Brief Summary

This trial assessed the efficacy of potassium competetor acid blocker (P-CAB) in the eradication of H.pylori

Detailed Description

The aim of this study is to compare the effectiveness of Vonaprazan based therapy vs.Proton Pump Inhibitor (PPI)based therapy for the eradication of H.Pylori infection in treatment naive and treatment experienced Egyptian patients.This prospective, non- randomized, controlled study was conducted on symptomatic patients admitted at Tropical Medicine Department at Ain Shams University Hospitals and those presenting at outpatient clinic. The study was conducted in the period from the 1st of January 2022 to the 1st of June 2023.

Study Timeline

• Study Start: 2022-01-01
• Primary Completion: 2023-06-01
• Study Completion: 2023-06-01
• Status Verified: 2023-10
• Study First Submitted: 2023-10-06
• Study First Submitted QC: 2023-10-24
• Last Update Submitted: 2023-10-24
• Study First Posted: 2023-10-26
• Last Update Posted: 2023-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 232

Inclusion Criteria

• Age above 18 years of both genders.
• Symptomatic patients who has been diagnosed to be H. pylori positive stool by using H. pylori stool antigen test.
• Patients who did not receive H. pylori eradication regimens before were included in group I of the study (First line eradication regimen).
• Patients who received only one eradication regimen before were included in group II of the study (Second line eradication regimen).
• Patients signing an informed consent.

Exclusion Criteria

• Patients refusing to sign an informed consent.
• Patients who were on PPIs, P-CABs and/or antibiotics starting one month before inclusion in the study .
• Patients who have chronic debilitating and advanced systemic diseases.
• Patients treated with low dose aspirin and/or non-steroidal anti-inflammatory drugs for a long time.
• Any lactating or pregnant female.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 4 Proton Pump Inhibitor Quadruple Therapy Arm	Vonoprazan	Fifty eight participants.The patients received a non-bismuth quadruple therapy (Levofloxacin 500 mg tablets OD + Esomeprazole 20mg tablets BID + Nitazoxanide 500 mg tablets BID +Doxycycline 100mg capsules OD) for 14 days
Arm 1 Vonoprazn Triple Therapy Arm	Vonoprazan	Fifty eight participants.The patients received (Clarithromycin 500 mg tablets twice daily\[BID\]+ Amoxicillin 1gm capsules BID + Vonoprazan 20 mg tablets BID) for 14 days
Arm 2 Proton Pump Inhibitor Triple Therapy Arm	Vonoprazan	Fifty eight participants.The patients received the classic triple therapy (Clarithromycin 500 mg tablets BID + Amoxicillin 1gm capsules BID + Esomeprazole 20 mg tablets BID) for 14 days
Arm 3 Vonoprazan Quadruple Therapy Arm	Vonoprazan	Fifty eight participants.The patients received a non-bismuth quadruple therapy (Levofloxacin 500 mg tablets once daily\[OD\] + Vonoprazan 20mg tablets BID + Nitazoxanide 500mg tablets BID +Doxycycline 100mg capsules OD) for 14 days.

Primary Outcome Measures

Name	Time	Method
H.pylori eradication	six weeks	The rate of the patients who achieved H.pylori eradication as measured by negative H.Pylori stool antigen test in the four arms of the study was reported.

Secondary Outcome Measures

Name	Time	Method
Safety of Vonoprazan use	six weeks	The number of patients who reported minor and major treatment connected adverse events in the four arms of the study was reported.

Trial Locations

Locations (1)

Faculty of Medicine Ain Shams University; 🇪🇬 Cairo, Egypt