HELICOBACTER PYLORI INFECTIONSPhase 4NCT07757919
Efficacy and Safety of 14-Day Vonoprazan-Minocycline Dual Therapy for Helicobacter Pylori Eradication
A Phase 4 study testing Vonoprazan-Amoxicillin Dual Therapy, Vonoprazan-Tetracycline Dual Therapy and Vonoprazan-Minocycline Dual Therapy in people with HELICOBACTER PYLORI INFECTIONS, run by Qilu Hospital of Shandong University.
Trial summary
Investigators will enroll treatment-naïve H. pylori-positive patients according to the inclusion and exclusion criteria in the trial. After obtaining written informed consent, investigators will open envelopes labeled with corresponding subject numbers in the order of subject enrollment to determine group allocation. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- HELICOBACTER PYLORI INFECTIONS
- What is being tested?
- Vonoprazan-Amoxicillin Dual Therapy, Vonoprazan-Tetracycline Dual Therapy and Vonoprazan-Minocycline Dual Therapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 492 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2026to 30 Dec 2027
- Phase
- Phase 4
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18-65 years, male or female.
- Helicobacter pylori-infected patients with positive ¹³C/¹⁴C urea breath test, and at least one positive result among the following three tests: Rapid Urease Test; Histopathological examination of gastric mucosal biopsy specimens; Stool Hp antigen test.
- No prior history of Helicobacter pylori eradication therapy.
Who cannot join
- Severe underlying diseases, such as hepatic insufficiency, renal insufficiency, malignant tumors, etc.
- Active gastrointestinal bleeding.
- History of upper gastrointestinal surgery.
- History of allergy to study medications.
- Use of antibiotics or bismuth agents within 1 month, or acid-suppressive agents within 2 weeks.
- Pregnant or lactating women.
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- Presence of other behaviors that may increase disease risks, such as heavy alcohol consumption, drug abuse, etc.
- Participation in other clinical trials within 3 months.
- Subjects unable or unwilling to provide written informed consent.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Efficacy and Safety of 14-Day Vonoprazan-Minocycline Dual Therapy for Helicobacter Pylori Eradication: A Multicenter, Non-Inferiority Randomized Controlled Trial
Investigators will enroll treatment-naïve H. pylori-positive patients according to the inclusion and exclusion criteria in the trial. After obtaining written informed consent, investigators will open envelopes labeled with corresponding subject numbers in the order of subject enrollment to determine group allocation. Subjects will receive interventions according to their assigned regimens: the 14-day vonoprazan-amoxicillin dual therapy regimen, the 14-day vonoprazan-tetracycline dual therapy regimen, or the 14-day vonoprazan-minocycline dual therapy regimen.
Meanwhile, investigators will complete the case report forms (CRFs) to record subjects' basic demographic information and risk factors for eradication failure. Subjects will be asked to fill out patient diaries to document medication administration and adverse reactions. After trial initiation, investigators will follow up with subjects via telephone or WeChat and collect patient diaries, summarize medication status and adverse reactions during treatment, and assess subject compliance.
Read more
Six weeks after the end of treatment, subjects will undergo a repeat ¹³C-urea breath test. Investigators will record treatment outcomes and re-examination results, finalize the case report forms, and upload photographs of original examination documents.
After all subjects finish the trial, the eradication rate, incidence of adverse events and subject compliance in each group will be calculated. Statistical analyses will be performed to compare demographic characteristics and risk factors between patients with eradication success and eradication failure. The findings will provide evidence for the selection of H. pylori eradication regimens.
- Conditions
- HELICOBACTER PYLORI INFECTIONS
- Being tested
- Vonoprazan-Amoxicillin Dual Therapy, Vonoprazan-Tetracycline Dual Therapy, Vonoprazan-Minocycline Dual Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vonoprazan-Amoxicillin Dual TherapyDrug
Medication Regimen:
Vonoprazan Fumarate Tablets: 1 tablet (20 mg) twice daily, taken 30 minutes before meals.
Amoxicillin Capsules: 4 capsules (0.25 g each) three times daily, taken immediately after meals.
Treatment duration:14 days
Vonoprazan-Tetracycline Dual TherapyDrug
Medication Regimen:
Vonoprazan Fumarate Tablets: 1 tablet (20 mg) twice daily, taken 30 minutes before meals.
Tetracycline Capsules: 2 capsules (0.25 g each) three times daily, taken immediately after meals.
Treatment duration:14 days
Vonoprazan-Minocycline Dual TherapyDrug
Medication Regimen:
Vonoprazan Fumarate Tablets: 1 tablet (20 mg) twice daily, taken 30 minutes before meals.
Minocycline Hydrochloride Capsules: 2 capsules (50 mg each) twice daily, taken immediately after meals.
Treatment duration:14 days
| Study group | Role | What they receive |
|---|---|---|
| 14-day vonoprazan-amoxicillin dual therapy regimen | Active comparator | Medication Regimen:
Vonoprazan Fumarate Tablets: 1 tablet (20 mg) twice daily, taken 30 minutes before meals.
Amoxicillin Capsules: 4 capsules (0.25 g each) three times daily, taken immediately after meals.
Treatment duration:14 days Receives: Drug: Vonoprazan-Amoxicillin Dual Therapy |
| 14-day vonoprazan-tetracycline dual therapy regimen | Active comparator | Medication Regimen:
Vonoprazan Fumarate Tablets: 1 tablet (20 mg) twice daily, taken 30 minutes before meals.
Tetracycline Tablets: 2 tablets (0.25 g each) three times daily, taken immediately after meals.
Treatment duration:14 days Receives: Drug: Vonoprazan-Tetracycline Dual Therapy |
| 14-day vonoprazan-minocycline dual therapy regimen | Experimental | Medication Regimen:
Vonoprazan Fumarate Tablets: 1 tablet (20 mg) twice daily, taken 30 minutes before meals.
Minocycline Hydrochloride Capsules: 2 capsules (50 mg each) twice daily, taken immediately after meals.
Treatment duration:14 days Receives: Drug: Vonoprazan-Minocycline Dual Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
¹³C-urea breath test
Measured: 6 weeks after the end of treatment
Secondary outcomes (2)
Adverse event rate
Measured: Within 1 week after the end of treatment
Participant compliance
Measured: Within 1 week after the end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2026
- Study start1 Sep 2026 (estimated)
- Primary completion30 Nov 2027 (estimated)
- Study completion30 Dec 2027 (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.
- More trials run by Qilu Hospital of Shandong 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 492 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qilu Hospital of Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07757919
- Sponsor's protocol ID
- KYLL-2026-06-012-1
- Status last verified
- Jul 2026
- First submitted
- 6 Aug 2026
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to patient privacy protection, institutional data management regulations and lack of formal data sharing agreement
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of 14-Day Vonoprazan-Minocycline Dual Therapy for Helicobacter Pylori Eradication: A Multicenter, Non-Inferiority Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07757919
- Acronym / sponsor ID
- KYLL-2026-06-012-1
- Conditions
- HELICOBACTER PYLORI INFECTIONS
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 492 participants (estimated)
- Lead sponsor
- Qilu Hospital of Shandong UniversityUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 30 Nov 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 11 Aug 2026 (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.
Investigators will enroll treatment-naïve H. pylori-positive patients according to the inclusion and exclusion criteria in the trial. After obtaining written informed consent, investigators will open envelopes labeled with corresponding subject numbers in the order of subject enrollment to determine group allocation. Subjects will receive interventions according to their assigned regimens: the 14-day vonoprazan-amoxicillin dual therapy regimen, the 14-day vonoprazan-tetracycline dual therapy regimen, or the 14-day vonoprazan-minocycline dual therapy regimen.
Meanwhile, investigators will complete the case report forms (CRFs) to record subjects' basic demographic information and risk factors for eradication failure. Subjects will be asked to fill out patient diaries to document medication administration and adverse reactions. After trial initiation, investigators will follow up with subjects via telephone or WeChat and collect patient diaries, summarize medication status and adverse reactions during treatment, and assess subject compliance.
Six weeks after the end of treatment, subjects will undergo a repeat ¹³C-urea breath test. Investigators will record treatment outcomes and re-examination results, finalize the case report forms, and upload photographs of original examination documents.
After all subjects finish the trial, the eradication rate, incidence of adverse events and subject compliance in each group will be calculated. Statistical analyses will be performed to compare demographic characteristics and risk factors between patients with eradication success and eradication failure. The findings will provide evidence for the selection of H. pylori eradication regimens.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 14-day vonoprazan-amoxicillin dual therapy regimen | Active comparator | Drug: Vonoprazan-Amoxicillin Dual TherapyMedication Regimen: Vonoprazan Fumarate Tablets: 1 tablet (20 mg) twice daily, taken 30 minutes before meals. Amoxicillin Capsules: 4 capsules (0.25 g each) three times daily, taken immediately after meals. Treatment duration:14 days |
| 14-day vonoprazan-tetracycline dual therapy regimen | Active comparator | Drug: Vonoprazan-Tetracycline Dual TherapyMedication Regimen: Vonoprazan Fumarate Tablets: 1 tablet (20 mg) twice daily, taken 30 minutes before meals. Tetracycline Tablets: 2 tablets (0.25 g each) three times daily, taken immediately after meals. Treatment duration:14 days |
| 14-day vonoprazan-minocycline dual therapy regimen | Experimental | Drug: Vonoprazan-Minocycline Dual TherapyMedication Regimen: Vonoprazan Fumarate Tablets: 1 tablet (20 mg) twice daily, taken 30 minutes before meals. Minocycline Hydrochloride Capsules: 2 capsules (50 mg each) twice daily, taken immediately after meals. Treatment duration:14 days |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged 18-65 years, male or female.
- Helicobacter pylori-infected patients with positive ¹³C/¹⁴C urea breath test, and at least one positive result among the following three tests: Rapid Urease Test; Histopathological examination of gastric mucosal biopsy specimens; Stool Hp antigen test.
- No prior history of Helicobacter pylori eradication therapy.
Key exclusion criteria (9 listed)
- Severe underlying diseases, such as hepatic insufficiency, renal insufficiency, malignant tumors, etc.
- Active gastrointestinal bleeding.
- History of upper gastrointestinal surgery.
- History of allergy to study medications.
- Use of antibiotics or bismuth agents within 1 month, or acid-suppressive agents within 2 weeks.
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 |
|---|---|---|
| Vonoprazan-Amoxicillin Dual TherapyMedication Regimen: Vonoprazan Fumarate Tablets: 1 tablet (20 mg) twice daily, taken 30 minutes before meals. Amoxicillin Capsules: 4 capsules (0.25 g each) three times daily, taken immediately after meals. Treatment duration:14 days | Drug | 14-day vonoprazan-amoxicillin dual therapy regimen |
| Vonoprazan-Tetracycline Dual TherapyMedication Regimen: Vonoprazan Fumarate Tablets: 1 tablet (20 mg) twice daily, taken 30 minutes before meals. Tetracycline Capsules: 2 capsules (0.25 g each) three times daily, taken immediately after meals. Treatment duration:14 days | Drug | 14-day vonoprazan-tetracycline dual therapy regimen |
| Vonoprazan-Minocycline Dual TherapyMedication Regimen: Vonoprazan Fumarate Tablets: 1 tablet (20 mg) twice daily, taken 30 minutes before meals. Minocycline Hydrochloride Capsules: 2 capsules (50 mg each) twice daily, taken immediately after meals. Treatment duration:14 days | Drug | 14-day vonoprazan-minocycline dual therapy regimen |
Primary outcome
¹³C-urea breath test
Time frame: 6 weeks after the end of treatment
2 secondary outcomes
Adverse event rate
Time frame: Within 1 week after the end of treatment
Participant compliance
Time frame: Within 1 week after the end of treatment
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 11 Aug 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to patient privacy protection, institutional data management regulations and lack of formal data sharing agreement
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Vonoprazan-Amoxicillin Dual Therapy, Vonoprazan-Tetracycline Dual Therapy and Vonoprazan-Minocycline Dual Therapy in people with HELICOBACTER PYLORI INFECTIONS, run by Qilu Hospital of Shandong University.
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 3 inclusion and 9 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: opening soon, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Li (+86 18560089751, lyynqj@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
¹³C-urea breath test (time frame: 6 weeks after the end of treatment). 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 11 Aug 2026.