Gastritis Clinical Trials

Find Gastritis Clinical Trials Near You

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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• Both male and female patients. • Patients ≥ 18 and \<80 years old.

⁃ Patients with confirmed diagnosis of H. pylori infection using either stool antigen test, urea breath test or endoscopy.

Locations
Other Locations
Egypt
Tanta university hospital
RECRUITING
Tanta
Contact Information
Primary
Hagar Khaled Dewidar, Msc in Clinical Pharmacy
hagar.dewidar@pharm.tanta.edu.eg
+201014679670
Time Frame
Start Date: 2026-02-15
Estimated Completion Date: 2026-12-20
Participants
Target number of participants: 66
Treatments
Active_comparator: Vonoprazan group
22 patients will receive vonoprazan (20 mg) with amoxicillin (1000 mg) and clarithromycin (500 mg) twice daily for 2 weeks
Active_comparator: Probiotic group
22 patients will receive proton pump inhibitor-based triple therapy omeprazole /pantoprazole (40 mg) with amoxicillin (1000 mg) and clarithromycin (500 mg) twice daily with lactobacillus acidophilus (5 billion CFU) three times daily for 2 weeks.
Active_comparator: Vitamin D group
22 patients will receive proton pump inhibitor-based triple therapy omeprazole /pantoprazole (40mg) with amoxicillin (1000 mg) and clarithromycin (500 mg) twice daily with vitamin D (2000 I.U.) once daily for 2 weeks.
Sponsors
Leads: Tanta University

This content was sourced from clinicaltrials.gov