Vonoprazan vs Proton Pump Inhibitor With Vitamin D or Probiotics Based Triple Therapy for Eradication of Helicobacter Pylori Infection

Summary

Helicobacter pylori is a Gram-negative, spiral-shaped bacterium that infects up to 50% of the world's population, residing in the gastric mucosa and using the mucus layer for protection from the stomach's high acidity. Its clinical significance is profound: it is classified as a Group 1 carcinogen by the World Health Organization and is a primary cause of chronic gastritis, peptic ulcers, gastric lymphoma, and gastric carcinoma. The current first-line treatment, a PPI-based triple therapy (PPI + clarithromycin + amoxicillin), is experiencing a decline in efficacy (cure rates of 50-70%) due to widespread antibiotic resistance and compliance issues. To overcome this, newer agents like Vonoprazan Fumarate, a Potassium-Competitive Acid Blocker (P-CAB), are being adopted. Vonoprazan works by reversibly inhibiting the H+, K+ ATPase pump achieving stronger and longer-lasting acid suppression than PPIs because it does not require acid activation and is more stable in an acidic environment. In addition to pharmacological treatment, adjunctive therapies show promise. Vitamin D, acting through Vitamin D Receptor (VDR), assists in eradication by upregulating antimicrobial proteins like beta-defensin and cathelicidin, and its metabolite can cause bacterial cell lysis. Probiotics (primarily Lactobacillus and Bifidobacterium strains) enhance eradication rates by restricting bacterial growth, inhibiting adhesion, and exerting an anti-inflammatory effect through decreased interleukin-8 production. Finally, helicobacter pylori infection is marked by significant inflammation and oxidative stress. The bacterial protein TIP alpha induces high levels of the pro-inflammatory cytokine TNF alpha. Furthermore, the infection increases free radical production, leading to oxidative stress reflected by high levels of malondialdehyde. Systemic inflammation is also evident as helicobacter pylori infection is associated with significantly elevated serum C-reactive protein levels, which decrease upon successful eradication.

Aim of the work:

This study aims at evaluating the safety and efficacy of Vonoprazan vs Proton Pump Inhibitor with Vitamin D or Probiotics Based Triple Therapy for Eradication of Helicobacter Pylori Infection.

Conditions

• HELICOBACTER PYLORI INFECTIONS
• Helicobacter Infection
• Helicobacter Pylori Gastrointestinal Tract Infection
• Helicobacter Pylori Infected Patients

Interventions

DRUG

Vonoparazan

Vonoprazan: Potassium competitive acid blocker

DRUG

Vitamin D

MIcronutrient

DRUG

Probiotic

Lactobacillus acidophilus

DRUG

Amoxicillin

Amoxicillin is penicillin-type antibiotic used to treat a wide range of bacterial infections.

DRUG

Clarithromycin 500 mg

Clarithromycin is a prescription macrolide antibiotic used to treat a variety of bacterial infections

DRUG

Proton Pump Inhibitor (PPI) Therapy

Proton Pump Inhibitors (PPIs) are powerful medications that significantly reduce stomach acid production by blocking the H+/K+ ATPase enzymes (proton pumps) in the stomach lining,

Sponsors & Collaborators

• Tanta University

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-02-15

Primary Completion

2026-12-20

Completion

2026-12-20

Countries

• Egypt

Study Locations