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Potassium Copetitive Acid Blockers Efficacy in H.Pylori Eradication

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06101420
Acronym
P-CABs
Enrollment
232
Registered
2023-10-26
Start date
2022-01-01
Completion date
2023-06-01
Last updated
2023-10-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Helicobacter Pylori Eradication

Keywords

P-CABs, Vonoprazan, H.pylori eradication

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.

Interventions

DRUGVonoprazan

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

Sponsors

Ain Shams University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
H.pylori eradicationsix weeksThe 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

MeasureTime frameDescription
Safety of Vonoprazan usesix weeksThe number of patients who reported minor and major treatment connected adverse events in the four arms of the study was reported.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026