Potassium Copetitive Acid Blockers Efficacy in H.Pylori Eradication

Helicobacter Pylori Eradication Clinical Trial

— P-CABs  

Official title:

Efficacy of Potassium Competitive Acid Blockers (P-CABs) Versus Proton Pump Inhibitors (PPIs) in the First and the Second Lines Eradication Regimens for H. Pylori in Egyptian Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06101420
• Other study ID #: 111954
• Status: Completed
• Phase: Phase 3
• Start date: January 1, 2022
• Est. completion date: June 1, 2023

Study information

• Verified date: October 2023
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 232
• Est. completion date: June 1, 2023
• Est. primary completion date: June 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Helicobacter Pylori Eradication

Intervention

Drug:
• Vonoprazan
Venoprazan 20mg twice daily,clarithromycin 500mg twice daily,amoxycillin 1 gm twice daily,esomeprazole 20mg twice daily,levofloxacin 500mg a single tablet daily,doxycicline 100mg a single capsule daily and nitazoxanide 500mg twice daily

Locations

Country	Name	City	State
Egypt	Faculty of Medicine Ain Shams University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	H.pylori eradication	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.	six weeks
Secondary	Safety of Vonoprazan use	The number of patients who reported minor and major treatment connected adverse events in the four arms of the study was reported.	six weeks