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

NCT07293910 | Recruiting Phase 2

• 1 other identifier: Helicobacter Pylori
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief 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 Gastrointestinal Tract Infection; Helicobacter Pylori Infected Patients; HELICOBACTER PYLORI INFECTIONS; Helicobacter Infection

Keywords

Helicobacter Pylori; Vonoprazan; Vitamin D; Probiotics; Lactobacillus; C-reactive protein; Tumor necrosis factor alpha; Malondialdehyde

Outcome Measures

Primary Outcomes (1)

• Detection of H pylori eradication difference among the three 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 groups It will be assessed as either positive or negative

  4 weeks after completion of therapy

Secondary Outcomes (2)

• Changes in serum levels of the measured biological markers

  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

  From baseline to completion of therapy and 4 weeks after completion of therapy

Study Arms (3)

Vonoprazan group

ACTIVE COMPARATOR

22 patients will receive vonoprazan (20 mg) with amoxicillin (1000 mg) and clarithromycin (500 mg) twice daily for 2 weeks

Drug: Vonoparazan; Drug: Amoxicillin; Drug: Clarithromycin 500 mg

Probiotic group

ACTIVE COMPARATOR

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.

Drug: Probiotic; Drug: Amoxicillin; Drug: Clarithromycin 500 mg; Drug: Proton Pump Inhibitor (PPI) Therapy

Vitamin D group

ACTIVE COMPARATOR

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.

Drug: Vitamin D; Drug: Amoxicillin; Drug: Clarithromycin 500 mg; Drug: Proton Pump Inhibitor (PPI) Therapy

Interventions

Clarithromycin 500 mg DRUG

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

Probiotic group; Vitamin D group; Vonoprazan group

Proton Pump Inhibitor (PPI) Therapy DRUG

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,

Probiotic group; Vitamin D group

Vonoparazan DRUG

Vonoprazan: Potassium competitive acid blocker

Vonoprazan group

Vitamin D DRUG

MIcronutrient

Vitamin D group

Probiotic DRUG

Lactobacillus acidophilus

Probiotic group

Amoxicillin DRUG

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

Probiotic group; Vitamin D group; Vonoprazan group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Patients with previous incidents of gastric or duodenal bleeding, gastric surgery or gastric malignancy.
• Patients with active liver disease.
• Patients with renal impairment.
• Concurrent use of liver enzyme inducers, inhibitors or drugs with high plasma protein binding.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta university hospital

Tanta, Egypt

RECRUITING

Related Publications (7)

• Gombart AF, Borregaard N, Koeffler HP. Human cathelicidin antimicrobial peptide (CAMP) gene is a direct target of the vitamin D receptor and is strongly up-regulated in myeloid cells by 1,25-dihydroxyvitamin D3. FASEB J. 2005 Jul;19(9):1067-77. doi: 10.1096/fj.04-3284com.

  PMID: 15985530 BACKGROUND

• Wanibuchi K, Hosoda K, Ihara M, Tajiri K, Sakai Y, Masui H, Takahashi T, Hirai Y, Shimomura H. Indene Compounds Synthetically Derived from Vitamin D Have Selective Antibacterial Action on Helicobacter pylori. Lipids. 2018 Apr;53(4):393-401. doi: 10.1002/lipd.12043. Epub 2018 May 16.

  PMID: 29766504 BACKGROUND

• Murakami K, Sakurai Y, Shiino M, Funao N, Nishimura A, Asaka M. Vonoprazan, a novel potassium-competitive acid blocker, as a component of first-line and second-line triple therapy for Helicobacter pylori eradication: a phase III, randomised, double-blind study. Gut. 2016 Sep;65(9):1439-46. doi: 10.1136/gutjnl-2015-311304. Epub 2016 Mar 2.

  PMID: 26935876 BACKGROUND

• Hori Y, Imanishi A, Matsukawa J, Tsukimi Y, Nishida H, Arikawa Y, Hirase K, Kajino M, Inatomi N. 1-[5-(2-Fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1H-pyrrol-3-yl]-N-methylmethanamine monofumarate (TAK-438), a novel and potent potassium-competitive acid blocker for the treatment of acid-related diseases. J Pharmacol Exp Ther. 2010 Oct;335(1):231-8. doi: 10.1124/jpet.110.170274. Epub 2010 Jul 12.

  PMID: 20624992 BACKGROUND

• Iannone A, Giorgio F, Russo F, Riezzo G, Girardi B, Pricci M, Palmer SC, Barone M, Principi M, Strippoli GF, Di Leo A, Ierardi E. New fecal test for non-invasive Helicobacter pylori detection: A diagnostic accuracy study. World J Gastroenterol. 2018 Jul 21;24(27):3021-3029. doi: 10.3748/wjg.v24.i27.3021.

  PMID: 30038469 BACKGROUND

• Schreiber S, Konradt M, Groll C, Scheid P, Hanauer G, Werling HO, Josenhans C, Suerbaum S. The spatial orientation of Helicobacter pylori in the gastric mucus. Proc Natl Acad Sci U S A. 2004 Apr 6;101(14):5024-9. doi: 10.1073/pnas.0308386101. Epub 2004 Mar 25.

  PMID: 15044704 BACKGROUND

• Ceylan A, Kirimi E, Tuncer O, Turkdogan K, Ariyuca S, Ceylan N. Prevalence of Helicobacter pylori in children and their family members in a district in Turkey. J Health Popul Nutr. 2007 Dec;25(4):422-7.

  PMID: 18402185 BACKGROUND

MeSH Terms

Conditions

Helicobacter Infections

Interventions

Vitamin D; Probiotics; Amoxicillin; Clarithromycin; Proton Pump Inhibitors; Therapeutics

Condition Hierarchy (Ancestors)

Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Organic Chemicals; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Erythromycin; Macrolides; Polyketides; Lactones; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses

Central Study Contacts

Hagar Khaled Dewidar, Msc in Clinical Pharmacy

CONTACT

+201014679670; hagar.dewidar@pharm.tanta.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer of Clinical Pharmacy

Study Record Dates

• First Submitted: December 8, 2025
• First Posted: December 19, 2025
• Study Start: February 15, 2026
• Primary Completion (Estimated): December 20, 2026
• Study Completion (Estimated): December 20, 2026
• Last Updated: February 13, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)