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

Ain Shams University

Status and phase: Completed; Phase 3

Conditions: Helicobacter Pylori Eradication

Treatments: Drug: Vonoprazan

Study type: Interventional

Funder types: Other

Identifiers

NCT06101420

111954

Details and patient eligibility

About

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

Full 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.

Enrollment: 232 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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232 participants in 4 patient groups

Arm 1 Vonoprazn Triple Therapy Arm

Experimental group

Description:

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

Treatment:

Drug: Vonoprazan

Arm 2 Proton Pump Inhibitor Triple Therapy Arm

Active Comparator group

Description:

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

Treatment:

Drug: Vonoprazan

Arm 3 Vonoprazan Quadruple Therapy Arm

Experimental group

Description:

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.

Treatment:

Drug: Vonoprazan

Arm 4 Proton Pump Inhibitor Quadruple Therapy Arm

Active Comparator group

Description:

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

Treatment:

Drug: Vonoprazan