Potassium-Competitive Acid BlockerNCT07165444
Potassium-Competitive Acid Blocker Versus Proton Pump Inhibitor as A Part of Bismuth Based Quadruple Therapy for Treatment of Helicobacter Pylori Infection
A study testing Potassium-Competitive Acid Blocker and Proton Pump Inhibitor in people with Potassium-Competitive Acid Blocker and Proton Pump Inhibitor, run by Tanta University at 1 site in Egypt.
Trial summary
This study aims to compare the eradication rate, safety, and patient adherence between potassium-competitive acid blockers (P-CABs) and proton pump inhibitor-based bismuth quadruple therapy in patients with Helicobacter pylori infection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Potassium-Competitive Acid Blocker, Proton Pump Inhibitor, Bismuth Based Quadruple Therapy
- What is being tested?
- Potassium-Competitive Acid Blocker and Proton Pump Inhibitor
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- 1 siteEgypt
- Study dates
- 11 Sep 2025to 1 Feb 2026
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged ≥18 years.
- Both sexes.
- Confirmed Helicobacter pylori infection by stool antigen (3rd-gen ELISA) or urea breath test (UBT).
- No prior eradication therapy.
Who cannot join
- Prior Helicobacter pylori treatment.
- Use of antibiotics, proton pump inhibitor, or bismuth in the prior 4 weeks.
- Gastric surgery history.
- Major organ failure.
- Pregnancy or lactation.
- Known allergy to study drugs.
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
Tanta University
Tanta, El-Gharbia, 31527
Mohamed G Flefel, MD, 00201009156988, mohamed.galal@med.tanta.edu.eg
Nashwa S Abdeen, MD
About this study
Official title: Potassium-Competitive Acid Blocker Versus Proton Pump Inhibitor as A Part of Bismuth Based Quadruple Therapy for Treatment of Helicobacter Pylori Infection: A Randomized Controlled Trial
This study aims to compare the eradication rate, safety, and patient adherence between potassium-competitive acid blockers (P-CABs) and proton pump inhibitor-based bismuth quadruple therapy in patients with Helicobacter pylori infection.
Read the detailed description
Helicobacter pylori (H. pylori) is a spiral-shaped, Gram-negative bacterium that colonizes the stomach lining and is considered one of the most prevalent chronic infections globally.
Bismuth-based quadruple therapy (proton pump inhibitor, bismuth, metronidazole, and tetracycline) is considered an effective alternative in cases of antibiotic resistance. This regimen achieves high eradication rates, even in areas with dual clarithromycin and metronidazole resistance.
Potassium-competitive acid blockers (P-CABs), such as vonoprazan, provide rapid, consistent, and strong acid suppression regardless of the CYP2C19 genotype.
- Conditions
- Potassium-Competitive Acid Blocker, Proton Pump Inhibitor, Bismuth Based Quadruple Therapy, Treatment, Helicobacter Pylori Infection
- Being tested
- Potassium-Competitive Acid Blocker, Proton Pump Inhibitor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Potassium-Competitive Acid BlockerDrug
Patients will a 10-day course of bismuth, metronidazole, tetracycline four times daily, and vonoprazan 20 mg twice daily.
Proton Pump InhibitorDrug
Patients will receive a 10-day course of bismuth, metronidazole, tetracycline four times daily, and rabeprazole 20 mg twice daily.
| Study group | Role | What they receive |
|---|---|---|
| B-CAP group | Experimental | Patients will a 10-day course of bismuth, metronidazole, tetracycline four times daily, and vonoprazan 20 mg twice daily. Receives: Drug: Potassium-Competitive Acid Blocker |
| PPI group | Active comparator | Patients will receive a 10-day course of bismuth, metronidazole, tetracycline four times daily, and rabeprazole 20 mg twice daily. Receives: Drug: Proton Pump Inhibitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Helicobacter pylori eradication
Helicobacter pylori eradication rate will be recorded.
Measured: 2 weeks after proton pump inhibitor
Secondary outcomes (3)
Adverse drug reactions
Adverse drug reactions will be recorded.
Measured: 2 weeks after proton pump inhibitor
Patient adherence
Adherence will be assessed by asking patients to return used packaging and by questioning.
Measured: 2 weeks after proton pump inhibitor
Degree of patient satisfaction
Degree of patient satisfaction will be assessed on a 5-point Likert scale patient satisfaction (1, extremely dissatisfied; 2, unsatisfied; 3, neutral; 4, satisfied; 5, extremely satisfied)
Measured: 2 weeks after proton pump inhibitor
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2025
- Study start11 Sep 2025
- Primary completion1 Feb 2026 (estimated)
- Study completion1 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Potassium-Competitive Acid BlockerStudies of the same condition, open and under way.
- More trials run by Tanta 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
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Galal Flefel, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07165444
- Sponsor's protocol ID
- 36264PR1285/7/25
- Status last verified
- Sep 2025
- First submitted
- 3 Sep 2025
- Last updated
- 12 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Potassium-Competitive Acid Blocker Versus Proton Pump Inhibitor as A Part of Bismuth Based Quadruple Therapy for Treatment of Helicobacter Pylori Infection: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07165444
- Acronym / sponsor ID
- 36264PR1285/7/25
- Conditions
- Potassium-Competitive Acid Blocker, Proton Pump Inhibitor, Bismuth Based Quadruple Therapy, Treatment, Helicobacter Pylori Infection
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 11 Sep 2025 (actual)
- Primary completion
- 1 Feb 2026 (estimated)
- Study completion
- 1 Feb 2026 (estimated)
- First posted
- 10 Sep 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 compare the eradication rate, safety, and patient adherence between potassium-competitive acid blockers (P-CABs) and proton pump inhibitor-based bismuth quadruple therapy in patients with Helicobacter pylori infection.
Detailed description
Helicobacter pylori (H. pylori) is a spiral-shaped, Gram-negative bacterium that colonizes the stomach lining and is considered one of the most prevalent chronic infections globally.
Bismuth-based quadruple therapy (proton pump inhibitor, bismuth, metronidazole, and tetracycline) is considered an effective alternative in cases of antibiotic resistance. This regimen achieves high eradication rates, even in areas with dual clarithromycin and metronidazole resistance.
Potassium-competitive acid blockers (P-CABs), such as vonoprazan, provide rapid, consistent, and strong acid suppression regardless of the CYP2C19 genotype.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| B-CAP group | Experimental | Drug: Potassium-Competitive Acid BlockerPatients will a 10-day course of bismuth, metronidazole, tetracycline four times daily, and vonoprazan 20 mg twice daily. |
| PPI group | Active comparator | Drug: Proton Pump InhibitorPatients will receive a 10-day course of bismuth, metronidazole, tetracycline four times daily, and rabeprazole 20 mg twice daily. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults aged ≥18 years.
- Both sexes.
- Confirmed Helicobacter pylori infection by stool antigen (3rd-gen ELISA) or urea breath test (UBT).
- No prior eradication therapy.
Key exclusion criteria (6 listed)
- Prior Helicobacter pylori treatment.
- Use of antibiotics, proton pump inhibitor, or bismuth in the prior 4 weeks.
- Gastric surgery history.
- Major organ failure.
- Pregnancy or lactation.
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 |
|---|---|---|
| Potassium-Competitive Acid BlockerPatients will a 10-day course of bismuth, metronidazole, tetracycline four times daily, and vonoprazan 20 mg twice daily. | Drug | B-CAP group |
| Proton Pump InhibitorPatients will receive a 10-day course of bismuth, metronidazole, tetracycline four times daily, and rabeprazole 20 mg twice daily. | Drug | PPI group |
Primary outcome
Helicobacter pylori eradication
Time frame: 2 weeks after proton pump inhibitor
Helicobacter pylori eradication rate will be recorded.
3 secondary outcomes
Adverse drug reactions
Time frame: 2 weeks after proton pump inhibitor
Patient adherence
Time frame: 2 weeks after proton pump inhibitor
Degree of patient satisfaction
Time frame: 2 weeks after proton pump inhibitor
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 12 Sep 2025.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Potassium-Competitive Acid Blocker and Proton Pump Inhibitor in people with Potassium-Competitive Acid Blocker and Proton Pump Inhibitor, run by Tanta 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 4 inclusion and 6 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 12 Sep 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 Mohamed G Flefel, MD (00201009156988, mohamed.galal@med.tanta.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Helicobacter pylori eradication (time frame: 2 weeks after proton pump inhibitor). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Sep 2025.