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.
Both male and female patients. • Patients ≥ 18 and <80 years old.
Pregnant or lactating patients. • Patients with inflammatory diseases. • Patients sensitive to any of the regimens' components. • Patients who had received a previous eradication therapy, recent use of antimicrobial agents, proton pump inhibitors, and H2 receptor blockers within 1 month.
Parallel
Vonoparazan
DrugVonoprazan: Potassium competitive acid blocker
Vitamin D
DrugMIcronutrient
Probiotic
DrugLactobacillus acidophilus
Amoxicillin
DrugAmoxicillin is penicillin-type antibiotic used to treat a wide range of bacterial infections.
Clarithromycin 500 mg
DrugClarithromycin is a prescription macrolide antibiotic used to treat a variety of bacterial infections
Proton Pump Inhibitor (PPI) Therapy
DrugProton 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,
Detection of H pylori eradication difference among the three intervention groups through stool antigen test 4 weeks after completion of therapy.
We will asses the presence or absence of H pylori through fecal antigen test four weeks after completion of therapy among the three intervention groups It will be assessed as either positive or negative
Changes in serum levels of the measured biological markers
The secondary outcome is the changes in serum levels of TNF-alpha, C-reactive protein and Malondialdehyde 4 weeks after completion of therapy
Change in Gastrointestinal Symptom Rating Scale Questionnaire total score from baseline to completion of therapy and 4 weeks after completion of therapy
change in Gastrointestinal Symptom Rating Scale Questionnaire total score from baseline to completion of therapy and 4 weeks after completion of therapy as it is a validated, 15-item questionnaire used to assess GI symptom severity, grouping symptoms into five clusters: Reflux, Abdominal Pain, Indigestion, Diarrhea, and Constipation, scored on a 1-7 Likert scale (1=no discomfort, 7=very severe).
Assessment CRP levels in both H-pylori positive and negative patients
Comparing the difference in CRP level in H-pylori positive and negative patients
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