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

NCT07045688 | Recruiting

• 1 other identifier: Soh-Med--25-5-10MS
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

H. Pylori Infection

Outcome Measures

Primary Outcomes (1)

• efficacy medical treatment for eradication of Helicobacter Pylori infection in naive patient.

  stool antigen for H. Pylori

  4 weeks after successful medical treatment

Study Arms (3)

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

ACTIVE COMPARATOR

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

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

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

ACTIVE COMPARATOR

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

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

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

ACTIVE COMPARATOR

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

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

Interventions

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

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

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

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

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

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

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

we assess the efficacy of PPI 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

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Sohag University Hospital

Sohag, Egypt

RECRUITING

Related Publications (3)

• 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.

  PMID: 27707777 BACKGROUND

• 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.

  PMID: 28071659 BACKGROUND

• 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.

  PMID: 33577874 BACKGROUND

Central Study Contacts

Andrew K Wadea, Resident

CONTACT

01211498813; andrewkameel511@gmail.com

Hamdy S Mohammed, Professor

CONTACT

01111101934

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident,Internal Medicine Departement , Faculty of Medicine Sohag university

Study Record Dates

• First Submitted: June 23, 2025
• First Posted: July 1, 2025
• Study Start: May 13, 2025
• Primary Completion: November 25, 2025
• Study Completion: November 25, 2025
• Last Updated: July 1, 2025

Record last verified: 2025-06

Locations

EG (1)