HELICOBACTER PYLORI INFECTIONSNCT07142798
to Assess the Eradication Rate of 14-day Bismuth/Amoxicillin/PCAB Triple Therapy for the Treatment of Helicobacter Pylori Infection
A study testing Bismuth amoxilillin potassium in people with HELICOBACTER PYLORI INFECTIONS, run by Kaohsiung Medical University at 1 site in Taiwan.
Trial summary
To assess the efficacy and safety of 14-day bismuth/amoxicillin/PCAB triple therapy for the treatment of Helicobacter pylori infection in Taiwan Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- HELICOBACTER PYLORI INFECTIONS
- What is being tested?
- Bismuth amoxilillin potassium
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteTaiwan
- Study dates
- 26 Sep 2024to 31 Jan 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects infected with Helicobacter pylori.
Who cannot join
- Those who are allergic to the drugs used in this research.
- Those who have had stomach surgery.
- Those with severe liver cirrhosis or uremia or malignant tumors.
- Women who are pregnant or breastfeeding. If you have drug allergies or pregnant women or breast-feeding women during the test period, you can withdraw from the test early.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Efficacy of Bismuth/Amoxicillin/Potassium-competitive Acid Blocker Triple Therapy for the Treatment of Helicobacter Pylori Infection in Taiwan
To assess the efficacy and safety of 14-day bismuth/amoxicillin/PCAB triple therapy for the treatment of Helicobacter pylori infection in Taiwan
- Conditions
- HELICOBACTER PYLORI INFECTIONS
- Being tested
- Bismuth amoxilillin potassium
- Keywords
- Helicobacter pylori therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bismuth amoxilillin potassiumDrug
vonoprazan 20mg， Twice a day amoxicillin 750mg，Four times a day tripotassium dicitrate bismuthate 300mg，Four times a day for 14 days
| Study group | Role | What they receive |
|---|---|---|
| Helicbpacyer pylori infection | Experimental | Helicbpacyer pylori infection Receives: Drug: Bismuth amoxilillin potassium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eradicaton rate of Helicobacter pylori
13CUBT
Measured: 6 weeks after finishing study drugs
Secondary outcomes (1)
evaluate side effect
evaluate drugy side effect by Questionnaire
Measured: 2days after taking medicine
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2025
- Study start26 Sep 2024
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kaohsiung Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- An-Nan Hospital, China Medical University
- Responsible party
- Principal investigator, DENG-CHYANG WU, Kaohsiung Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07142798
- Sponsor's protocol ID
- KMUHIRB-F(I)-20240204
- Status last verified
- Aug 2025
- First submitted
- 19 Aug 2025
- Last updated
- 27 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Bismuth/Amoxicillin/Potassium-competitive Acid Blocker Triple Therapy for the Treatment of Helicobacter Pylori Infection in Taiwan
- ClinicalTrials.gov ID
- NCT07142798
- Acronym / sponsor ID
- KMUHIRB-F(I)-20240204
- Conditions
- HELICOBACTER PYLORI INFECTIONS
- Keywords
- Helicobacter pylori therapy
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Kaohsiung Medical UniversityUniversity, hospital or other
- Collaborators
- An-Nan Hospital, China Medical University
- Study start
- 26 Sep 2024 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Jan 2026 (estimated)
- First posted
- 27 Aug 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.
To assess the efficacy and safety of 14-day bismuth/amoxicillin/PCAB triple therapy for the treatment of Helicobacter pylori infection in Taiwan
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Helicbpacyer pylori infection | Experimental | Drug: Bismuth amoxilillin potassiumHelicbpacyer pylori infection |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Subjects infected with Helicobacter pylori.
Key exclusion criteria (4 listed)
- Those who are allergic to the drugs used in this research.
- Those who have had stomach surgery.
- Those with severe liver cirrhosis or uremia or malignant tumors.
- Women who are pregnant or breastfeeding. If you have drug allergies or pregnant women or breast-feeding women during the test period, you can withdraw from the test early.
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 |
|---|---|---|
| Bismuth amoxilillin potassiumvonoprazan 20mg， Twice a day amoxicillin 750mg，Four times a day tripotassium dicitrate bismuthate 300mg，Four times a day for 14 days | Drug | Helicbpacyer pylori infection |
Primary outcome
Eradicaton rate of Helicobacter pylori
Time frame: 6 weeks after finishing study drugs
13CUBT
1 secondary outcome
evaluate side effect
Time frame: 2days after taking medicine
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 27 Aug 2025.
- Individual participant dataSharing planned: No
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HELICOBACTER PYLORI INFECTIONS
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HELICOBACTER PYLORI INFECTIONS
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bismuth amoxilillin potassium in people with HELICOBACTER PYLORI INFECTIONS, run by Kaohsiung Medical University at 1 site in Taiwan.
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 1 inclusion and 4 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: enrolling by invitation, as of the sponsor's last update on 27 Aug 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 Taiwan. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Eradicaton rate of Helicobacter pylori (time frame: 6 weeks after finishing study drugs). 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 27 Aug 2025.