Efficacy of Vonoprazan Based Dual and Triple Therapy for Patient With Helicobacter Pylori Infection

NCT ID: NCT07045688

Last Updated: 2025-07-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-13

Study Completion Date

2025-11-25

Brief Summary

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This study aims to assess Efficacy of vonoprazan based dual and triple therapy for naïve patient with Helicopacter Pylori infection in Sohag Government .

Detailed Description

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Conditions

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H. Pylori Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Efficacy of Vonoprazan based dual therapy for naive patient with Helicobacter Pylori infection

we assess the efficacy of Vonoprazan based dual therapy for eradication of Helicobacter Pylori infection in naive patient.

Group Type ACTIVE_COMPARATOR

Efficacy of Vonoprazan based dual therapy for naive patient with Helicobacter Pylori infection

Intervention Type DRUG

we assess the efficacy of Vonoprazan based dual therapy for eradication of Helicobacter Pylori infection in naive patient.

Efficacy of Vonoprazan based triple therapy for naive patient with Helicobacter Pylori infection

we assess the efficacy of Vonoprazan based triple therapy for eradication of Helicobacter Pylori infection in naive patient.

Group Type ACTIVE_COMPARATOR

Efficacy of Vonoprazan based triple therapy for naive patient with Helicobacter Pylori infection

Intervention Type DRUG

we assess the efficacy of Vonoprazan based triple therapy for eradication of Helicobacter Pylori infection in naive patient.

Efficacy of PPI based triple therapy for naive patient with Helicobacter Pylori infection

we assess the efficacy of proton pump inhibitors (PPI) based dual therapy for eradication of Helicobacter Pylori infection in naive patient.

Group Type ACTIVE_COMPARATOR

Efficacy of PPI based triple therapy for naive patient with Helicobacter Pylori infection

Intervention Type DRUG

we assess the efficacy of PPI based triple therapy for eradication of Helicobacter Pylori infection in naive patient.

Interventions

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Efficacy of Vonoprazan based dual therapy for naive patient with Helicobacter Pylori infection

we assess the efficacy of Vonoprazan based dual therapy for eradication of Helicobacter Pylori infection in naive patient.

Intervention Type DRUG

Efficacy of Vonoprazan based triple therapy for naive patient with Helicobacter Pylori infection

we assess the efficacy of Vonoprazan based triple therapy for eradication of Helicobacter Pylori infection in naive patient.

Intervention Type DRUG

Efficacy of PPI based triple therapy for naive patient with Helicobacter Pylori infection

we assess the efficacy of PPI based triple therapy for eradication of Helicobacter Pylori infection in naive patient.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Age: \>18 years old.
* H. pylori infection: Confirmed by histopathology or non-invasive tests (e.g., stool antigen test).

Exclusion Criteria

* Prior H. pylori treatment: Previous treatment for H. pylori infection.
* Allergies: Known allergies to study medications or components.
* Patients cannot finish treatment course.
* Patient missed follow up.
* Patients refusing or neglecting test of cure for H. pylori.
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sohag University

OTHER

Sponsor Role lead

Responsible Party

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Andrew Kamil Wadie

Resident,Internal Medicine Departement , Faculty of Medicine Sohag university

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Sohag University Hospital

Sohag, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Andrew K Wadea, Resident

Role: CONTACT

01211498813

Hamdy S Mohammed, Professor

Role: CONTACT

01111101934

Facility Contacts

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Magdy M Amin, Professor

Role: primary

01090801900

References

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Malfertheiner P, Megraud F, O'Morain CA, Gisbert JP, Kuipers EJ, Axon AT, Bazzoli F, Gasbarrini A, Atherton J, Graham DY, Hunt R, Moayyedi P, Rokkas T, Rugge M, Selgrad M, Suerbaum S, Sugano K, El-Omar EM; European Helicobacter and Microbiota Study Group and Consensus panel. Management of Helicobacter pylori infection-the Maastricht V/Florence Consensus Report. Gut. 2017 Jan;66(1):6-30. doi: 10.1136/gutjnl-2016-312288. Epub 2016 Oct 5.

Reference Type BACKGROUND
PMID: 27707777 (View on PubMed)

Chey WD, Leontiadis GI, Howden CW, Moss SF. ACG Clinical Guideline: Treatment of Helicobacter pylori Infection. Am J Gastroenterol. 2017 Feb;112(2):212-239. doi: 10.1038/ajg.2016.563. Epub 2017 Jan 10.

Reference Type BACKGROUND
PMID: 28071659 (View on PubMed)

Argueta EA, Alsamman MA, Moss SF, D'Agata EMC. Impact of Antimicrobial Resistance Rates on Eradication of Helicobacter pylori in a US Population. Gastroenterology. 2021 May;160(6):2181-2183.e1. doi: 10.1053/j.gastro.2021.02.014. Epub 2021 Feb 9. No abstract available.

Reference Type BACKGROUND
PMID: 33577874 (View on PubMed)

Other Identifiers

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Soh-Med--25-5-10MS

Identifier Type: -

Identifier Source: org_study_id

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