Comparative Study Evaluating Safety and Effectiveness of ( Proton Pump Inhibitor Versus Vonoprazan ) Based Triple Therapy With or Without Zinc to Eradicate H. Pylori Infection
NCT ID: NCT07275827
Last Updated: 2025-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE3
88 participants
INTERVENTIONAL
2026-02-01
2026-10-31
Brief Summary
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Detailed Description
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Vonoprazan is a novel drug of the K-competitive acid blockers (P-CABs) whose producing stronger and longer-lasting suppression of gastric acid because they are unaffected by the CYP2C19 polymorphism. In addition to their powerful acid-inhibitory effect, vonoprazan-based regimens have been shown to be effective against resistant H. pylori strains and was proved to be non-inferior to susceptibility-guided proton pump inhibitor based therapy (PPI).
P-CABs based triple therapy consisted of the newly discovered Vonoprazan 20 mg twice daily and amoxicillin (1000mg) plus clarithromycin 500 mg twice daily. PPI-based triple therapy regimen consisted of (Omeprazole /pantoprazole 40mg) with amoxicillin (1000mg) and clarithromycin (500mg) twice daily for 14 days, Successful eradication was confirmed at least 4 weeks after finishing the treatment according to ACG guidelines .
Zinc is a not only fairly active element but also strong reducing agent, which plays a vital role in human organisms as an essential microelement.
Zinc, as an important structural element, is often at catalytic center of many biomacromolecules and enzymes, which is essential for proper functioning of biomacromolecules and enzymes .
Until now, some researchers have focused on development of drugs containing zinc to enhance elimination for pathogenic bacteria and virus. appropriate concentrations of zinc can inhibit the growth of or kill H. pylori .
Studies regarding the effect of Zn compounds on the eradication of H. pylori infection have been limited. However, polaprezinc in combination with the triple therapy (lansoprazole, amoxicillin, clarithromycin) significantly improved the cure rate of H. pylori infection in mice with no increase in side effects .
H. pylori is involved in the development of 80% of gastric cancers and 5.5% of all malignant conditions worldwide. Its persistence within the host's stomach causes chronic inflammation, which is a well-known hallmark of carcinogenesis. A wide range of cytokines were reported to be involved in the initiation and long-term persistence of this local and systemic inflammation.
IL-6 is a cytokine that plays an important role in the acquired immune response by stimulation of antibody production, development of effector T-cell and promote differentiation or proliferation of several nonimmune cells .
Recently it was found that IL-6 and H. pylori infections contributed to the appearance and development of gastric cancer. It is believed that IL-6 has the important clinical significance in the early diagnosis of gastric cancer . In the gastric mucosa, pepsinogen II (PgII) is produced/secreted by glands in the mucus-secreting antral and cardia compartments. PgII serology may provide clinically useful information on gastric inflammatory diseases, and as a marker of H. pylori status, in both H. pylori-positive patients and after eradication therapy .
This is a randomized, controlled, prospective, parallel study that will be conducted on 88 patients infected with Helicobacter pylori and they will be divided into four groups
The primary clinical outcome is to investigate the difference in eradication rate of H. pylori infection between the four treatment groups, and this can be confirmed by the negative result of stool antigen test of the infected patients.
The secondary outcome is the changes in serum levels of biological biomarkers and the change in Gastrointestinal Symptom Rating Scale (GSRS) total score from baseline to the end of the study period (after eradication therapy).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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proton pump inhibitor (PPI) with amoxicillin , without addition of zinc sulphate
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.
proton pump inhibitor + amoxicillin
Effect of using proton pump inhibitor + amoxicillin in Helicobacter pylori Treatment
proton pump inhibitor (PPI) with amoxicillin , with addition of zinc sulphate
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 .
zinc sulfate
Effect of using Zinc in Helicobacter pylori Treatment
proton pump inhibitor + amoxicillin
Effect of using proton pump inhibitor + amoxicillin in Helicobacter pylori Treatment
vonoprazan with amoxicillin and clarithromycin without using zinc sulphate
22 patients will receive potassium-competitive acid blocker (vonoprazan 20 mg with amoxicillin 1000mg and clarithromycin 500mg twice daily) for 2 weeks.
Vonoprazan + amoxicillin + clarithromycin
Effect of using Vonoprazan + amoxicillin + clarithromycin in Helicobacter pylori Treatment
vonoprazan with amoxicillin and clarithromycin with addition of zinc sulphate
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 .
zinc sulfate
Effect of using Zinc in Helicobacter pylori Treatment
Vonoprazan + amoxicillin + clarithromycin
Effect of using Vonoprazan + amoxicillin + clarithromycin in Helicobacter pylori Treatment
Interventions
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zinc sulfate
Effect of using Zinc in Helicobacter pylori Treatment
Vonoprazan + amoxicillin + clarithromycin
Effect of using Vonoprazan + amoxicillin + clarithromycin in Helicobacter pylori Treatment
proton pump inhibitor + amoxicillin
Effect of using proton pump inhibitor + amoxicillin in Helicobacter pylori Treatment
Eligibility Criteria
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Inclusion Criteria
* Both males and females.
* Patients who are positive for H.pylori infection by non-invasive Stool Antigen Test (SAT).
Exclusion Criteria
* 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.
19 Years
ALL
No
Sponsors
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Tanta University
OTHER
Responsible Party
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Dina Samir Ahmed Attalla
Pharmacist
Locations
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National Liver Institute
Shibīn al Kawm, , Egypt
Countries
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Central Contacts
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Facility Contacts
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Eman A Mahmoud
Role: primary
References
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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.
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.
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.
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.
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.
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.
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.
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.
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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.
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.
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Other Identifiers
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Gastroenterology
Identifier Type: -
Identifier Source: org_study_id