Comparative Study Evaluating Safety and Effectiveness of ( Proton Pump Inhibitor Versus Vonoprazan ) Based Triple Therapy With or Without Zinc to Eradicate H. Pylori Infection

NCT07275827 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: Gastroenterology
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief Summary

this Study Evaluating Safety and Effectiveness of (Proton Pump Inhibitor versus Vonoprazan) Based Triple Therapy with or without Zinc to Eradicate H. pylori Infection

Conditions

HELICOBACTER PYLORI INFECTIONS

Outcome Measures

Primary Outcomes (3)

• Serum interleukin-6 (IL-6) level: will be assessed by ELISA

  \- Blood samples: collected from all participants at base line before PPI based triple therapy (Omeprazole /pantoprazole 40mg with amoxicillin 1000mg and clarithromycin 500mg twice daily), 220mg Zinc Sulphate which is equivalent to 50mg elemental zinc and P-CABs based triple therapy (Vonoprazan 20 mg and amoxicillin 1000mg plus clarithromycin 500 mg twice daily) , and then 4 weeks after finishing the treatment from each group for the assessment of the f by Serum interleukin-6 (IL-6) level: will be assessed by ELISA.

  8 weeks

• H. pylori stool antigen test (SAT)

  \- H. pylori stool antigen test (SAT): test at base line for diagnosis and then 4 weeks after finishing the treatment

  8 weeks

• Serum Pepsinogen level: will be assessed by ELISA.

  Blood samples: collected from all participants at base line before PPI based triple therapy (Omeprazole /pantoprazole 40mg with amoxicillin 1000mg and clarithromycin 500mg twice daily), 220mg Zinc Sulphate which is equivalent to 50mg elemental zinc and P-CABs based triple therapy (Vonoprazan 20 mg and amoxicillin 1000mg plus clarithromycin 500 mg twice daily) , and then 4 weeks after finishing the treatment from each group for the assessment of the f by Serum Pepsinogen level: will be assessed by ELISA.

  8 weeks

Study Arms (4)

proton pump inhibitor (PPI) with amoxicillin , without addition of zinc sulphate

ACTIVE COMPARATOR

22 patients will receive proton pump inhibitor (PPI)-based triple therapy (Omeprazole /pantoprazole 40mg) with amoxicillin (1000mg) and clarithromycin (500mg) twice daily for 2 weeks.

Drug: proton pump inhibitor + amoxicillin

proton pump inhibitor (PPI) with amoxicillin , with addition of zinc sulphate

ACTIVE COMPARATOR

22 patients will receive proton pump inhibitor (PPI)-based triple therapy (Omeprazole /pantoprazole 40mg with amoxicillin 1000mg and clarithromycin 500mg twice daily) Plus 220mg Zinc Sulphate which is equivalent to 50mg elemental zinc for 2 weeks .

Drug: zinc sulfate; Drug: proton pump inhibitor + amoxicillin

vonoprazan with amoxicillin and clarithromycin without using zinc sulphate

ACTIVE COMPARATOR

22 patients will receive potassium-competitive acid blocker (vonoprazan 20 mg with amoxicillin 1000mg and clarithromycin 500mg twice daily) for 2 weeks.

Drug: Vonoprazan + amoxicillin + clarithromycin

vonoprazan with amoxicillin and clarithromycin with addition of zinc sulphate

ACTIVE COMPARATOR

22 patients will receive potassium-competitive acid blocker (vonoprazan 20 mg with amoxicillin 1000mg and clarithromycin 500mg twice daily) Plus 220mg Zinc Sulphate which is equivalent to 50mg elemental zinc for 2 weeks .

Drug: zinc sulfate; Drug: Vonoprazan + amoxicillin + clarithromycin

Interventions

Vonoprazan + amoxicillin + clarithromycin DRUG

Effect of using Vonoprazan + amoxicillin + clarithromycin in Helicobacter pylori Treatment

vonoprazan with amoxicillin and clarithromycin with addition of zinc sulphate; vonoprazan with amoxicillin and clarithromycin without using zinc sulphate

zinc sulfate DRUG

Effect of using Zinc in Helicobacter pylori Treatment

proton pump inhibitor (PPI) with amoxicillin , with addition of zinc sulphate; vonoprazan with amoxicillin and clarithromycin with addition of zinc sulphate

proton pump inhibitor + amoxicillin DRUG

Effect of using proton pump inhibitor + amoxicillin in Helicobacter pylori Treatment

proton pump inhibitor (PPI) with amoxicillin , with addition of zinc sulphate; proton pump inhibitor (PPI) with amoxicillin , without addition of zinc sulphate

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 18.
• Both males and females.
• Patients who are positive for H.pylori infection by non-invasive Stool Antigen Test (SAT).

You may not qualify if:

• Prior H. pylori treatment: Previous treatment for H. pylori infection.
• Allergies: Known allergies to study medications or components.
• Patients cannot finish treatment course.
• Pregnant and Lactating Women.
• Patients with Kidney disease and eGFR \< 30ml/min.
• Patients with Liver disease with Child-Pugh B or C.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

National Liver Institute

Shibīn al Kawm, Egypt

Location

Related Publications (19)

• Ono S, Kato M, Nakagawa S, Mabe K, Sakamoto N. Vonoprazan improves the efficacy of Helicobacter pylori eradication therapy with a regimen consisting of clarithromycin and metronidazole in patients allergic to penicillin. Helicobacter. 2017 Jun;22(3). doi: 10.1111/hel.12374. Epub 2017 Jan 18.

  PMID: 28098408 RESULT

• Kulich KR, Madisch A, Pacini F, Pique JM, Regula J, Van Rensburg CJ, Ujszaszy L, Carlsson J, Halling K, Wiklund IK. Reliability and validity of the Gastrointestinal Symptom Rating Scale (GSRS) and Quality of Life in Reflux and Dyspepsia (QOLRAD) questionnaire in dyspepsia: a six-country study. Health Qual Life Outcomes. 2008 Jan 31;6:12. doi: 10.1186/1477-7525-6-12.

  PMID: 18237386 RESULT

• Di Mario F, Crafa P, Barchi A, Franzoni L, Franceschi M, Russo M, Bricca L, Brozzi L, Rodriguez Castro K, Rugge M. Pepsinogen II in gastritis and Helicobacter pylori infection. Helicobacter. 2022 Apr;27(2):e12872. doi: 10.1111/hel.12872. Epub 2022 Jan 8.

  PMID: 34997989 RESULT

• Sanchez-Zauco N, Torres J, Gomez A, Camorlinga-Ponce M, Munoz-Perez L, Herrera-Goepfert R, Medrano-Guzman R, Giono-Cerezo S, Maldonado-Bernal C. Circulating blood levels of IL-6, IFN-gamma, and IL-10 as potential diagnostic biomarkers in gastric cancer: a controlled study. BMC Cancer. 2017 May 30;17(1):384. doi: 10.1186/s12885-017-3310-9.

  PMID: 28558708 RESULT

• Rasool KH, Mahmood Alubadi AE, Al-Bayati IFI. The role of Serum Interleukin-4 and Interleukin-6 in Helicobacter pylori-infected patients. Microb Pathog. 2022 Jan;162:105362. doi: 10.1016/j.micpath.2021.105362. Epub 2021 Dec 20.

  PMID: 34942310 RESULT

• Dinca AL, Melit LE, Marginean CO. Old and New Aspects of H. pylori-Associated Inflammation and Gastric Cancer. Children (Basel). 2022 Jul 20;9(7):1083. doi: 10.3390/children9071083.

  PMID: 35884067 RESULT

• Mahmoud A, Abuelazm M, Ahmed AAS, Abdalshafy H, Abdelazeem B, Brasic JR. Efficacy and Safety of Polaprezinc-Based Therapy versus the Standard Triple Therapy for Helicobacter pylori Eradication: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Nutrients. 2022 Oct 4;14(19):4126. doi: 10.3390/nu14194126.

  PMID: 36235778 RESULT

• Tran CD, Campbell MA, Kolev Y, Chamberlain S, Huynh HQ, Butler RN. Short-term zinc supplementation attenuates Helicobacter felis-induced gastritis in the mouse. J Infect. 2005 Jun;50(5):417-24. doi: 10.1016/j.jinf.2004.07.008.

  PMID: 15907550 RESULT

• Elsaadany E, Amin S, Abdel-Hafez M, El Amrousy D, Kasem S, Abd Elaziz D, Shawky D. Study of Serum Ferritin, Zinc, and Copper Levels in Children With Helicobacter pylori Gastritis and the Effect of the Treatment. J Pediatr Gastroenterol Nutr. 2022 Nov 1;75(5):e88-e93. doi: 10.1097/MPG.0000000000003585. Epub 2022 Aug 3.

  PMID: 35929980 RESULT

• Fan D, Gong Y, Sun L, Zhang Y, Zhang J. Comparative transcriptome analysis to investigate the mechanism of anti-Helicobacter pylori activity of zinc. Microb Pathog. 2022 Jul;168:105611. doi: 10.1016/j.micpath.2022.105611. Epub 2022 Jun 1.

  PMID: 35660509 RESULT

• Kim YS, Kim SJ, Yoon JH, Suk KT, Kim JB, Kim DJ, Kim DY, Min HJ, Park SH, Shin WG, Kim KH, Kim HY, Baik GH. Randomised clinical trial: the efficacy of a 10-day sequential therapy vs. a 14-day standard proton pump inhibitor-based triple therapy for Helicobacter pylori in Korea. Aliment Pharmacol Ther. 2011 Nov;34(9):1098-105. doi: 10.1111/j.1365-2036.2011.04843.x. Epub 2011 Sep 19.

  PMID: 21923713 RESULT

• Shekeban YM, Hamdy NA, Header DA, Ahmed SM, Helmy MM. Vonoprazan-based therapy versus standard regimen for Helicobacter pylori infection management in Egypt: an open-label randomized controlled trial. Sci Rep. 2025 May 8;15(1):15989. doi: 10.1038/s41598-025-98606-8.

  PMID: 40341536 RESULT

• Alsulaimany FAS, Awan ZA, Almohamady AM, Koumu MI, Yaghmoor BE, Elhady SS, Elfaky MA. Prevalence of Helicobacter pylori Infection and Diagnostic Methods in the Middle East and North Africa Region. Medicina (Kaunas). 2020 Apr 9;56(4):169. doi: 10.3390/medicina56040169.

  PMID: 32283700 RESULT

• Wong KI, Wang S, Li M, Zhao G, Wang C, Wu L, Fan H, Yao M, Lu M. Combating drug-resistant helicobacter pylori infection with zinc peroxide-based nanoparticles: a ROS reservoir via photochemical reaction. Chemical Engineering Journal. 2024 Mar 1;483:149287.

  RESULT

• He Z, Jiang H, Zhang X, Zhang H, Cui Z, Sun L, Li H, Qian J, Ma J, Huang J. Nano-delivery vehicle based on chlorin E6, photodynamic therapy, doxorubicin chemotherapy provides targeted treatment of HER-2 negative, alphanubeta3-positive breast cancer. Pharmacol Res. 2020 Oct;160:105184. doi: 10.1016/j.phrs.2020.105184. Epub 2020 Sep 15.

  PMID: 32946931 RESULT

• Nie M, Deng DM, Wu Y, de Oliveira KT, Bagnato VS, Crielaard W, Rastelli ANS. Photodynamic inactivation mediated by methylene blue or chlorin e6 against Streptococcus mutans biofilm. Photodiagnosis Photodyn Ther. 2020 Sep;31:101817. doi: 10.1016/j.pdpdt.2020.101817. Epub 2020 May 12.

  PMID: 32407890 RESULT

• Wang Y, Wang Y, Wang Y, Murray CK, Hamblin MR, Hooper DC, Dai T. Antimicrobial blue light inactivation of pathogenic microbes: State of the art. Drug Resist Updat. 2017 Nov;33-35:1-22. doi: 10.1016/j.drup.2017.10.002. Epub 2017 Oct 13.

  PMID: 29145971 RESULT

• Gerrits MM, van Vliet AH, Kuipers EJ, Kusters JG. Helicobacter pylori and antimicrobial resistance: molecular mechanisms and clinical implications. Lancet Infect Dis. 2006 Nov;6(11):699-709. doi: 10.1016/S1473-3099(06)70627-2.

  PMID: 17067919 RESULT

• Goodwin CS, Mendall MM, Northfield TC. Helicobacter pylori infection. Lancet. 1997 Jan 25;349(9047):265-9. doi: 10.1016/S0140-6736(96)07023-7. No abstract available.

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MeSH Terms

Interventions

Zinc Sulfate; 1-(5-(2-fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1H-pyrrol-3-yl)-N-methylmethanamine; Amoxicillin; Clarithromycin; Proton Pump Inhibitors

Intervention Hierarchy (Ancestors)

Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds; Inorganic Chemicals; Zinc Compounds; Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Organic Chemicals; 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

Eman A Mahmoud, Prof.

CONTACT

+201002415022; eabdelsameea@liver-eg.eg

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pharmacist

Study Record Dates

• First Submitted: November 27, 2025
• First Posted: December 10, 2025
• Study Start: February 1, 2026
• Primary Completion: April 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: December 24, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)