Clinical trial · Interventional
Vonoprazan vs Proton Pump Inhibitor With Vitamin D or Probiotics Based Triple Therapy for Eradication of Helicobacter Pylori Infection
Safety and Efficacy of Vonoprazan vs Proton Pump Inhibitor With Vitamin D or Probiotics Based Triple Therapy for Eradication of Helicobacter Pylori Infection
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 10, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260910-000001
Summary
Brief summary (as posted)
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
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Helicobacter Infection | — | UNRESOLVED | — |
| Helicobacter Pylori Gastrointestinal Tract Infection | — | UNRESOLVED | — |
| Helicobacter Pylori Infected Patients | — | UNRESOLVED | — |
| HELICOBACTER PYLORI INFECTIONS | — | UNRESOLVED | — |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Amoxicillin | Drug | — | UNRESOLVED |
| Clarithromycin 500 mg | Drug | — | UNRESOLVED |
| Probiotic | Drug | — | UNRESOLVED |
| Proton Pump Inhibitor (PPI) Therapy | Drug | — | UNRESOLVED |
| Vitamin D | Drug | — | UNRESOLVED |
| Vonoparazan | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- ACTIVE_COMPARATOR
- label
- Vonoprazan group
- description
- 22 patients will receive vonoprazan (20 mg) with amoxicillin (1000 mg) and clarithromycin (500 mg) twice daily for 2 weeks
- interventionNames
- Drug: Vonoparazan
- Drug: Amoxicillin
- Drug: Clarithromycin 500 mg
- type
- ACTIVE_COMPARATOR
- label
- Probiotic group
- description
- 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.
- interventionNames
- Drug: Probiotic
- Drug: Amoxicillin
- Drug: Clarithromycin 500 mg
- Drug: Proton Pump Inhibitor (PPI) Therapy
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * 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 (n=66) Patient whom are confirmed to be H-pylori negative using either stool antigen test, urea breath test or endoscopy (n=66) Exclusion Criteria: * 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.
References
Publications (7)
- BACKGROUNDGombart 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
- BACKGROUNDWanibuchi 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
- BACKGROUNDMurakami 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
- BACKGROUNDHori 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
- BACKGROUNDIannone 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
- BACKGROUNDSchreiber 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.