HELICOBACTER PYLORI INFECTIONSPhase 3NCT07275827
Comparative Study Evaluating Safety and Effectiveness of ( Proton Pump Inhibitor Versus Vonoprazan ) Based Triple Therapy With or Without Zinc to Eradicate H. Pylori Infection
A Phase 3 study testing zinc sulfate, Vonoprazan + amoxicillin + clarithromycin and proton pump inhibitor + amoxicillin in people with HELICOBACTER PYLORI INFECTIONS, run by Tanta University at 1 site in Egypt.
Trial 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 Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- HELICOBACTER PYLORI INFECTIONS
- What is being tested?
- zinc sulfate, Vonoprazan + amoxicillin + clarithromycin and proton pump inhibitor + amoxicillin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2026to Feb 2027
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18.
- Both males and females.
- Patients who are positive for H.pylori infection by non-invasive Stool Antigen Test (SAT).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
National Liver Institute
Shibīn al Kawm
Eman A Mahmoud, +201002415022, eabdelsameea@liver-eg.org
About this study
this Study Evaluating Safety and Effectiveness of (Proton Pump Inhibitor versus Vonoprazan) Based Triple Therapy with or without Zinc to Eradicate H. pylori Infection
Read the detailed description
Helicobacter pylori is a microaerobic Gram-negative bacterium, which predominantly colonizes the human stomach and duodenum, typically residing on the surface of the gastric mucosal epithelium and mucous layer . Current research has identified H. pylori as a carcinogen capable of inducing chronic atrophic gastritis, gastrointestinal metaplasia, dysplasia, and adenocarcinoma, posing a significant health risk . Moreover, it is associated with common gastrointestinal conditions such as chronic gastritis and peptic ulcers .
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 .
- 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
- HELICOBACTER PYLORI INFECTIONS
- Being tested
- zinc sulfate, Vonoprazan + amoxicillin + clarithromycin, proton pump inhibitor + amoxicillin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
zinc sulfateDrug
Effect of using Zinc in Helicobacter pylori Treatment
Vonoprazan + amoxicillin + clarithromycinDrug
Effect of using Vonoprazan + amoxicillin + clarithromycin in Helicobacter pylori Treatment
proton pump inhibitor + amoxicillinDrug
Effect of using proton pump inhibitor + amoxicillin in Helicobacter pylori Treatment
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 . Receives: 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. Receives: 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 . Receives: Drug: zinc sulfate; Drug: Vonoprazan + amoxicillin + clarithromycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2025
- Study start1 Feb 2026
- Primary completionDec 2026 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for HELICOBACTER PYLORI INFECTIONSStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dina Samir Ahmed Attalla, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07275827
- Sponsor's protocol ID
- Gastroenterology
- Status last verified
- Dec 2025
- First submitted
- 27 Nov 2025
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 28098408Kulich 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.
PubMed 18237386Di 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.
PubMed 34997989Sanchez-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.
PubMed 28558708Rasool 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.
PubMed 34942310Dinca 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.
PubMed 35884067Mahmoud 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.
PubMed 36235778Tran 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.
PubMed 15907550Elsaadany 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.
PubMed 35929980Fan 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.
PubMed 35660509Kim 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.
PubMed 21923713Shekeban 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.
PubMed 40341536Alsulaimany 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.
PubMed 32283700Wong 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.
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.
PubMed 32946931