H. Pylori InfectionNCT07045688
Efficacy of Vonoprazan Based Dual and Triple Therapy for Patient With Helicobacter Pylori Infection
A study testing Efficacy of Vonoprazan based dual therapy for naive patient with Helicobacter Pylori infection, Efficacy of Vonoprazan based triple therapy for naive patient with Helicobacter Pylori infection and Efficacy of PPI based triple therapy for naive patient with Helicobacter Pylori infection in people with H. Pylori Infection, run by Sohag University at 1 site in Egypt.
Trial summary
This study aims to assess Efficacy of vonoprazan based dual and triple therapy for naïve patient with Helicopacter Pylori infection in Sohag Government . Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- H. Pylori Infection
- What is being tested?
- Efficacy of Vonoprazan based dual therapy for naive patient with Helicobacter Pylori infection, Efficacy of Vonoprazan based triple therapy for naive patient with Helicobacter Pylori infection and Efficacy of PPI based triple therapy for naive patient with Helicobacter Pylori infection
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteEgypt
- Study dates
- 13 May 2025to 25 Nov 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years old.
- H. pylori infection: Confirmed by histopathology or non-invasive tests (e.g., stool antigen test).
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.
- Patient missed follow up.
- Patients refusing or neglecting test of cure for H. pylori.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hamdy S Mohammed, Professor contact
Egypt1 site, 1 recruiting
- Recruiting
Sohag University Hospital
Sohag
Magdy M Amin, Professor, 01090801900
About this study
Official title: Efficacy of Vonoprazan Based Dual and Triple Therapy for Naive Patient With Helicobacter Pylori Infection
This study aims to assess Efficacy of vonoprazan based dual and triple therapy for naïve patient with Helicopacter Pylori infection in Sohag Government .
- Conditions
- H. Pylori Infection
- Being tested
- Efficacy of Vonoprazan based dual therapy for naive patient with Helicobacter Pylori infection, Efficacy of Vonoprazan based triple therapy for naive patient with Helicobacter Pylori infection, Efficacy of PPI based triple therapy for naive patient with Helicobacter Pylori infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Efficacy of Vonoprazan based dual therapy for naive patient with Helicobacter Pylori infectionDrug
we assess the efficacy of Vonoprazan based dual therapy for eradication of Helicobacter Pylori infection in naive patient.
Efficacy of Vonoprazan based triple therapy for naive patient with Helicobacter Pylori infectionDrug
we assess the efficacy of Vonoprazan based triple therapy for eradication of Helicobacter Pylori infection in naive patient.
Efficacy of PPI based triple therapy for naive patient with Helicobacter Pylori infectionDrug
we assess the efficacy of PPI based triple therapy for eradication of Helicobacter Pylori infection in naive patient.
| Study group | Role | What they receive |
|---|---|---|
| Efficacy of Vonoprazan based dual therapy for naive patient with Helicobacter Pylori infection | Active comparator | we assess the efficacy of Vonoprazan based dual therapy for eradication of Helicobacter Pylori infection in naive patient. Receives: Drug: Efficacy of Vonoprazan based dual therapy for naive patient with Helicobacter Pylori infection |
| Efficacy of Vonoprazan based triple therapy for naive patient with Helicobacter Pylori infection | Active comparator | we assess the efficacy of Vonoprazan based triple therapy for eradication of Helicobacter Pylori infection in naive patient. Receives: Drug: Efficacy of Vonoprazan based triple therapy for naive patient with Helicobacter Pylori infection |
| Efficacy of PPI based triple therapy for naive patient with Helicobacter Pylori infection | Active comparator | we assess the efficacy of proton pump inhibitors (PPI) based dual therapy for eradication of Helicobacter Pylori infection in naive patient. Receives: Drug: Efficacy of PPI based triple therapy for naive patient with Helicobacter Pylori infection |
What is being measured
The primary outcome is the main question the study is designed to answer.
efficacy medical treatment for eradication of Helicobacter Pylori infection in naive patient.
stool antigen for H. Pylori
Measured: 4 weeks after successful medical treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2025
- Study start13 May 2025
- Primary completion25 Nov 2025 (estimated)
- Study completion25 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for H. Pylori InfectionStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrew Kamil Wadie, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07045688
- Sponsor's protocol ID
- Soh-Med--25-5-10MS
- Status last verified
- Jun 2025
- First submitted
- 23 Jun 2025
- Last updated
- 1 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Malfertheiner P, Megraud F, O'Morain CA, Gisbert JP, Kuipers EJ, Axon AT, Bazzoli F, Gasbarrini A, Atherton J, Graham DY, Hunt R, Moayyedi P, Rokkas T, Rugge M, Selgrad M, Suerbaum S, Sugano K, El-Omar EM; European Helicobacter and Microbiota Study Group and Consensus panel. Management of Helicobacter pylori infection-the Maastricht V/Florence Consensus Report. Gut. 2017 Jan;66(1):6-30. doi: 10.1136/gutjnl-2016-312288. Epub 2016 Oct 5.
PubMed 27707777Chey WD, Leontiadis GI, Howden CW, Moss SF. ACG Clinical Guideline: Treatment of Helicobacter pylori Infection. Am J Gastroenterol. 2017 Feb;112(2):212-239. doi: 10.1038/ajg.2016.563. Epub 2017 Jan 10.
PubMed 28071659Argueta EA, Alsamman MA, Moss SF, D'Agata EMC. Impact of Antimicrobial Resistance Rates on Eradication of Helicobacter pylori in a US Population. Gastroenterology. 2021 May;160(6):2181-2183.e1. doi: 10.1053/j.gastro.2021.02.014. Epub 2021 Feb 9. No abstract available.
PubMed 33577874
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Vonoprazan Based Dual and Triple Therapy for Naive Patient With Helicobacter Pylori Infection
- ClinicalTrials.gov ID
- NCT07045688
- Acronym / sponsor ID
- Soh-Med--25-5-10MS
- Conditions
- H. Pylori Infection
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 13 May 2025 (actual)
- Primary completion
- 25 Nov 2025 (estimated)
- Study completion
- 25 Nov 2025 (estimated)
- First posted
- 1 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to assess Efficacy of vonoprazan based dual and triple therapy for naïve patient with Helicopacter Pylori infection in Sohag Government .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Efficacy of Vonoprazan based dual therapy for naive patient with Helicobacter Pylori infection | Active comparator | Drug: Efficacy of Vonoprazan based dual therapy for naive patient with Helicobacter Pylori infectionwe assess the efficacy of Vonoprazan based dual therapy for eradication of Helicobacter Pylori infection in naive patient. |
| Efficacy of Vonoprazan based triple therapy for naive patient with Helicobacter Pylori infection | Active comparator | Drug: Efficacy of Vonoprazan based triple therapy for naive patient with Helicobacter Pylori infectionwe assess the efficacy of Vonoprazan based triple therapy for eradication of Helicobacter Pylori infection in naive patient. |
| Efficacy of PPI based triple therapy for naive patient with Helicobacter Pylori infection | Active comparator | Drug: Efficacy of PPI based triple therapy for naive patient with Helicobacter Pylori infectionwe assess the efficacy of proton pump inhibitors (PPI) based dual therapy for eradication of Helicobacter Pylori infection in naive patient. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age: >18 years old.
- H. pylori infection: Confirmed by histopathology or non-invasive tests (e.g., stool antigen test).
Key exclusion criteria (5 listed)
- Prior H. pylori treatment: Previous treatment for H. pylori infection.
- Allergies: Known allergies to study medications or components.
- Patients cannot finish treatment course.
- Patient missed follow up.
- Patients refusing or neglecting test of cure for H. pylori.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Efficacy of Vonoprazan based dual therapy for naive patient with Helicobacter Pylori infectionwe assess the efficacy of Vonoprazan based dual therapy for eradication of Helicobacter Pylori infection in naive patient. | Drug | Efficacy of Vonoprazan based dual therapy for naive patient with Helicobacter Pylori infection |
| Efficacy of Vonoprazan based triple therapy for naive patient with Helicobacter Pylori infectionwe assess the efficacy of Vonoprazan based triple therapy for eradication of Helicobacter Pylori infection in naive patient. | Drug | Efficacy of Vonoprazan based triple therapy for naive patient with Helicobacter Pylori infection |
| Efficacy of PPI based triple therapy for naive patient with Helicobacter Pylori infectionwe assess the efficacy of PPI based triple therapy for eradication of Helicobacter Pylori infection in naive patient. | Drug | Efficacy of PPI based triple therapy for naive patient with Helicobacter Pylori infection |
Primary outcome
efficacy medical treatment for eradication of Helicobacter Pylori infection in naive patient.
Time frame: 4 weeks after successful medical treatment
stool antigen for H. Pylori
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2025.
- Background: PubMed 27707777Malfertheiner P, Megraud F, O'Morain CA, Gisbert JP, Kuipers EJ, Axon AT, Bazzoli F, Gasbarrini A, Atherton J, Graham DY, Hunt R, Moayyedi P, Rokkas T, Rugge M, Selgrad M, Suerbaum S, Sugano K, El-Omar EM; European Helicobacter and Microbiota Study Group and Consensus panel. Management of Helicobacter pylori infection-the Maastricht V/Florence Consensus Report. Gut. 2017 Jan;66(1):6-30. doi: 10.1136/gutjnl-2016-312288. Epub 2016 Oct 5.
- Background: PubMed 28071659Chey WD, Leontiadis GI, Howden CW, Moss SF. ACG Clinical Guideline: Treatment of Helicobacter pylori Infection. Am J Gastroenterol. 2017 Feb;112(2):212-239. doi: 10.1038/ajg.2016.563. Epub 2017 Jan 10.
- Background: PubMed 33577874Argueta EA, Alsamman MA, Moss SF, D'Agata EMC. Impact of Antimicrobial Resistance Rates on Eradication of Helicobacter pylori in a US Population. Gastroenterology. 2021 May;160(6):2181-2183.e1. doi: 10.1053/j.gastro.2021.02.014. Epub 2021 Feb 9. No abstract available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hamdy S Mohammed, Professor contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Efficacy of Vonoprazan based dual therapy for naive patient with Helicobacter Pylori infection, Efficacy of Vonoprazan based triple therapy for naive patient with Helicobacter Pylori infection and Efficacy of PPI based triple therapy for naive patient with Helicobacter Pylori infection in people with H. Pylori Infection, run by Sohag University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Andrew K Wadea, Resident (01211498813, andrewkameel511@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
efficacy medical treatment for eradication of Helicobacter Pylori infection in naive patient. (time frame: 4 weeks after successful medical treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07045688, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2025.