Comparative Study Evaluating Safety and Effectiveness of ( Proton Pump Inhibitor Versus Vonoprazan ) Based Triple Therapy With or Without Zinc to Eradicate H. Pylori Infection

December 18, 2025 updated by: Dina Samir Ahmed Attalla, Tanta University
this Study Evaluating Safety and Effectiveness of (Proton Pump Inhibitor versus Vonoprazan) Based Triple Therapy with or without Zinc to Eradicate H. pylori Infection

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Helicobacter pylori is a microaerobic Gram-negative bacterium, which predominantly colonizes the human stomach and duodenum, typically residing on the surface of the gastric mucosal epithelium and mucous layer . Current research has identified H. pylori as a carcinogen capable of inducing chronic atrophic gastritis, gastrointestinal metaplasia, dysplasia, and adenocarcinoma, posing a significant health risk . Moreover, it is associated with common gastrointestinal conditions such as chronic gastritis and peptic ulcers .

Vonoprazan is a novel drug of the K-competitive acid blockers (P-CABs) whose producing stronger and longer-lasting suppression of gastric acid because they are unaffected by the CYP2C19 polymorphism. In addition to their powerful acid-inhibitory effect, vonoprazan-based regimens have been shown to be effective against resistant H. pylori strains and was proved to be non-inferior to susceptibility-guided proton pump inhibitor based therapy (PPI).

P-CABs based triple therapy consisted of the newly discovered Vonoprazan 20 mg twice daily and amoxicillin (1000mg) plus clarithromycin 500 mg twice daily. PPI-based triple therapy regimen consisted of (Omeprazole /pantoprazole 40mg) with amoxicillin (1000mg) and clarithromycin (500mg) twice daily for 14 days, Successful eradication was confirmed at least 4 weeks after finishing the treatment according to ACG guidelines .

Zinc is a not only fairly active element but also strong reducing agent, which plays a vital role in human organisms as an essential microelement.

Zinc, as an important structural element, is often at catalytic center of many biomacromolecules and enzymes, which is essential for proper functioning of biomacromolecules and enzymes .

Until now, some researchers have focused on development of drugs containing zinc to enhance elimination for pathogenic bacteria and virus. appropriate concentrations of zinc can inhibit the growth of or kill H. pylori .

Studies regarding the effect of Zn compounds on the eradication of H. pylori infection have been limited. However, polaprezinc in combination with the triple therapy (lansoprazole, amoxicillin, clarithromycin) significantly improved the cure rate of H. pylori infection in mice with no increase in side effects .

H. pylori is involved in the development of 80% of gastric cancers and 5.5% of all malignant conditions worldwide. Its persistence within the host's stomach causes chronic inflammation, which is a well-known hallmark of carcinogenesis. A wide range of cytokines were reported to be involved in the initiation and long-term persistence of this local and systemic inflammation.

IL-6 is a cytokine that plays an important role in the acquired immune response by stimulation of antibody production, development of effector T-cell and promote differentiation or proliferation of several nonimmune cells .

Recently it was found that IL-6 and H. pylori infections contributed to the appearance and development of gastric cancer. It is believed that IL-6 has the important clinical significance in the early diagnosis of gastric cancer . In the gastric mucosa, pepsinogen II (PgII) is produced/secreted by glands in the mucus-secreting antral and cardia compartments. PgII serology may provide clinically useful information on gastric inflammatory diseases, and as a marker of H. pylori status, in both H. pylori-positive patients and after eradication therapy .

This is a randomized, controlled, prospective, parallel study that will be conducted on 88 patients infected with Helicobacter pylori and they will be divided into four groups

The primary clinical outcome is to investigate the difference in eradication rate of H. pylori infection between the four treatment groups, and this can be confirmed by the negative result of stool antigen test of the infected patients.

The secondary outcome is the changes in serum levels of biological biomarkers and the change in Gastrointestinal Symptom Rating Scale (GSRS) total score from baseline to the end of the study period (after eradication therapy).

Study Type

Interventional

Enrollment (Estimated)

88

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age > 18.
  • Both males and females.
  • Patients who are positive for H.pylori infection by non-invasive Stool Antigen Test (SAT).

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.
  • Pregnant and Lactating Women.
  • Patients with Kidney disease and eGFR < 30ml/min.
  • Patients with Liver disease with Child-Pugh B or C.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: proton pump inhibitor (PPI) with amoxicillin , without addition of zinc sulphate
22 patients will receive proton pump inhibitor (PPI)-based triple therapy (Omeprazole /pantoprazole 40mg) with amoxicillin (1000mg) and clarithromycin (500mg) twice daily for 2 weeks.
Drug: proton pump inhibitor + amoxicillin
Effect of using proton pump inhibitor + amoxicillin in Helicobacter pylori Treatment
Active Comparator: proton pump inhibitor (PPI) with amoxicillin , with addition of zinc sulphate
22 patients will receive proton pump inhibitor (PPI)-based triple therapy (Omeprazole /pantoprazole 40mg with amoxicillin 1000mg and clarithromycin 500mg twice daily) Plus 220mg Zinc Sulphate which is equivalent to 50mg elemental zinc for 2 weeks .
Drug: zinc sulfate
Effect of using Zinc in Helicobacter pylori Treatment
Drug: proton pump inhibitor + amoxicillin
Effect of using proton pump inhibitor + amoxicillin in Helicobacter pylori Treatment
Active Comparator: vonoprazan with amoxicillin and clarithromycin without using zinc sulphate
22 patients will receive potassium-competitive acid blocker (vonoprazan 20 mg with amoxicillin 1000mg and clarithromycin 500mg twice daily) for 2 weeks.
Drug: Vonoprazan + amoxicillin + clarithromycin
Effect of using Vonoprazan + amoxicillin + clarithromycin in Helicobacter pylori Treatment
Active Comparator: vonoprazan with amoxicillin and clarithromycin with addition of zinc sulphate
22 patients will receive potassium-competitive acid blocker (vonoprazan 20 mg with amoxicillin 1000mg and clarithromycin 500mg twice daily) Plus 220mg Zinc Sulphate which is equivalent to 50mg elemental zinc for 2 weeks .
Drug: zinc sulfate
Effect of using Zinc in Helicobacter pylori Treatment
Drug: Vonoprazan + amoxicillin + clarithromycin
Effect of using Vonoprazan + amoxicillin + clarithromycin in Helicobacter pylori Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum interleukin-6 (IL-6) level: will be assessed by ELISA
Time Frame: 8 weeks
- Blood samples: collected from all participants at base line before PPI based triple therapy (Omeprazole /pantoprazole 40mg with amoxicillin 1000mg and clarithromycin 500mg twice daily), 220mg Zinc Sulphate which is equivalent to 50mg elemental zinc and P-CABs based triple therapy (Vonoprazan 20 mg and amoxicillin 1000mg plus clarithromycin 500 mg twice daily) , and then 4 weeks after finishing the treatment from each group for the assessment of the f by Serum interleukin-6 (IL-6) level: will be assessed by ELISA.
8 weeks
H. pylori stool antigen test (SAT)
Time Frame: 8 weeks
- H. pylori stool antigen test (SAT): test at base line for diagnosis and then 4 weeks after finishing the treatment
8 weeks
Serum Pepsinogen level: will be assessed by ELISA.
Time Frame: 8 weeks
Blood samples: collected from all participants at base line before PPI based triple therapy (Omeprazole /pantoprazole 40mg with amoxicillin 1000mg and clarithromycin 500mg twice daily), 220mg Zinc Sulphate which is equivalent to 50mg elemental zinc and P-CABs based triple therapy (Vonoprazan 20 mg and amoxicillin 1000mg plus clarithromycin 500 mg twice daily) , and then 4 weeks after finishing the treatment from each group for the assessment of the f by Serum Pepsinogen level: will be assessed by ELISA.
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tanta University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2026

Primary Completion (Estimated)

April 1, 2026

Study Completion (Estimated)

October 1, 2026

Study Registration Dates

First Submitted

November 27, 2025

First Submitted That Met QC Criteria

November 27, 2025

First Posted (Estimated)

December 10, 2025

Study Record Updates

Last Update Posted (Actual)

December 24, 2025

Last Update Submitted That Met QC Criteria

December 18, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Gastroenterology

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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