P-CABs: Potassium Copetitive Acid Blockers Efficacy in H.Pylori Eradication

Sponsor

Ain Shams University (Other)

Overall Status

Completed

CT.gov ID

NCT06101420

Collaborator

(none)

232

Enrollment

Location

Arms

Actual Duration (Months)

13.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Helicobacter Pylori Eradication	Drug: Vonoprazan	Phase 3

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 Design

Study Type:

Interventional

Actual Enrollment :

232 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Jan 1, 2022

Actual Primary Completion Date :

Jun 1, 2023

Actual Study Completion Date :

Jun 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm 1 Vonoprazn Triple Therapy Arm 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	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 Other Names: Clarithromycin Amoxycillin Esomeprazole Levofloxacin Doxycicline Nitazoxanide
Active Comparator: Arm 2 Proton Pump Inhibitor Triple Therapy Arm 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	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 Other Names: Clarithromycin Amoxycillin Esomeprazole Levofloxacin Doxycicline Nitazoxanide
Experimental: Arm 3 Vonoprazan Quadruple Therapy Arm 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.	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 Other Names: Clarithromycin Amoxycillin Esomeprazole Levofloxacin Doxycicline Nitazoxanide
Active Comparator: Arm 4 Proton Pump Inhibitor Quadruple Therapy Arm 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	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 Other Names: Clarithromycin Amoxycillin Esomeprazole Levofloxacin Doxycicline Nitazoxanide

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.