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

Tanta University

Status and phase: Not yet enrolling; Phase 3

Conditions: HELICOBACTER PYLORI INFECTIONS

Treatments: Drug: zinc sulfate; Drug: proton pump inhibitor + amoxicillin; Drug: Vonoprazan + amoxicillin + clarithromycin

Study type: Interventional

Funder types: Other

Identifiers

NCT07275827

Gastroenterology

Details and patient eligibility

About

this Study Evaluating Safety and Effectiveness of (Proton Pump Inhibitor versus Vonoprazan) Based Triple Therapy with or without Zinc to Eradicate H. pylori Infection

Full 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).

Enrollment: 88 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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88 participants in 4 patient groups

proton pump inhibitor (PPI) with amoxicillin , without addition of zinc sulphate

Active Comparator group

Description:

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.

Treatment:

Drug: proton pump inhibitor + amoxicillin

proton pump inhibitor (PPI) with amoxicillin , with addition of zinc sulphate

Active Comparator group

Description:

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 .

Treatment:

Drug: proton pump inhibitor + amoxicillin

Drug: zinc sulfate

vonoprazan with amoxicillin and clarithromycin without using zinc sulphate

Active Comparator group

Description:

22 patients will receive potassium-competitive acid blocker (vonoprazan 20 mg with amoxicillin 1000mg and clarithromycin 500mg twice daily) for 2 weeks.

Treatment:

Drug: Vonoprazan + amoxicillin + clarithromycin

vonoprazan with amoxicillin and clarithromycin with addition of zinc sulphate

Active Comparator group

Description:

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 .

Treatment:

Drug: Vonoprazan + amoxicillin + clarithromycin

Drug: zinc sulfate