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Completed

NCT Number: NCT06101420

Potassium Copetitive Acid Blockers Efficacy in H.Pylori Eradication

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

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Key information

Conditions

Helicobacter Pylori Eradication

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Faculty of Medicine Ain Shams University

Cairo, 11341, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Vonoprazan

Drug

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

Primary outcomes

  1. H.pylori eradication

    Time frame: 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 outcomes

  1. Safety of Vonoprazan use

    Time frame: six weeks

    The number of patients who reported minor and major treatment connected adverse events in the four arms of the study was reported.

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study 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

Acronym: P-CABs

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Oct 26, 2023
Registry last updated
Oct 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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