Helicobacter Pylori InfectionNCT06412588
Dual Therapy With Vonoprazan Plus Amoxicillin or Doxycycline Versus Bismuth Quadruple Therapy for Helicobacter Pylori Eradication.
A study testing Vonoprazan+amoxicillin+doxycycline+bismuth for 14 days, Vonoprazan+Amoxicillin and Vonoprazan+doxycycline in people with Helicobacter Pylori Infection, run by Nanjing First Hospital, Nanjing Medical University at 1 site in China.
Trial summary
It is planned to select Hp infection patients in a number of tertiary hospitals in Jiangsu and randomly divide them into three groups: group A is the classic group, receiving Vonoprazan 20mg, bid + amoxicillin 1.0g, bid + doxycycline 0.1g, bid + colloidal pectin bismuth 0.3g, bid and group C are double groups… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Helicobacter Pylori Infection
- What is being tested?
- Vonoprazan+amoxicillin+doxycycline+bismuth for 14 days, Vonoprazan+Amoxicillin and Vonoprazan+doxycycline
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 579 participants
- Where
- 1 siteChina
- Study dates
- 15 Jun 2024to 10 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18-65 years old;
- Patients confirmed to be positive for H. pylori by 13C-UBT or 14C-UBT;
- Patients who have not received Helicobacter pylori eradication therapy before, or patients who have failed to eradicate in the early stage but have not received eradication therapy within half a year;
- Voluntarily join this trial and sign the informed consent form.
Who cannot join
- Allergy to the study drug (penicillin, amoxicillin, Vonoprazan, doxycycline, etc.);
- Patients with confirmed active peptic ulcer;
- Patients who have received Helicobacter pylori eradication therapy within half a year;
- Use of antibiotics, bismuth, and histamine H2 receptor antagonists or PPIs for the first 2 weeks before starting study treatment;
- Use of adrenocorticosteroids, non-steroidal anti-inflammatory drugs, anticoagulants, barbiturates, phenytoin, or carbamazepine drugs;
- History of esophageal or gastric surgery;
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- Pregnant or lactating women;
- Alcoholism
- Suffering from serious concomitant diseases, such as liver disease, cardiovascular disease, lung disease, kidney disease;
- Hepatic insufficiency caused by hepatitis, fatty liver and other reasons;
- Gastric mucosa-associated lymphoid tissue lymphoma (MALT), malignant tumor diseases.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dual Therapy With Vonoprazan Plus Amoxicillin or Doxycycline Versus Bismuth Quadruple Therapy for Helicobacter Pylori Eradication:A Prospective, Multicenter, Open-label Randomized Controlled Study
It is planned to select Hp infection patients in a number of tertiary hospitals in Jiangsu and randomly divide them into three groups: group A is the classic group, receiving Vonoprazan 20mg, bid + amoxicillin 1.0g, bid + doxycycline 0.1g, bid + colloidal pectin bismuth 0.3g, bid and group C are double groups, respectively, receiving standard dose amoxicillin (1.0 g, bid) combined with vonorrasan dual regimen and doxycycline (0.1g, bid) combined with Vonoprazan dual regimen, the treatment course of the three groups was 14 days, and the oral dose of Vonoprazan was 20mg, bid, the eradication rate, adverse reactions, compliance and other aspects of the three groups were compared, In order to obtain a safe, efficient, economical and convenient Hp eradication program with a wider range of applications.
Read the detailed description
It is planned to select Hp infection patients in a number of tertiary hospitals in Jiangsu and randomly divide them into three groups: group A is the classic group, receiving Vonoprazan 20mg, bid + amoxicillin 1.0g, bid + doxycycline 0.1g, bid + colloidal pectin bismuth 0.3g, bid and group C are double groups, respectively, receiving standard dose amoxicillin (1.0 g, bid) combined with vonorrasan dual regimen and doxycycline (0.1g, bid) combined with vonorrasan dual regimen, the treatment course of the three groups was 14 days, and the oral dose of Vonoprazan was 20mg, bid, the eradication rate, adverse reactions, compliance and other aspects of the three groups were compared, In order to obtain a safe, efficient, economical and convenient Hp eradication program with a wider range of applications.
- Conditions
- Helicobacter Pylori Infection
- Being tested
- Vonoprazan+amoxicillin+doxycycline+bismuth for 14 days, Vonoprazan+Amoxicillin, Vonoprazan+doxycycline
- Keywords
- Helicobacter Pylori Infection, Dual therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vonoprazan+amoxicillin+doxycycline+bismuth for 14 daysDrug
Also called Doxycycline-based Bismuth Quadruple Therapy
Group A:The patient was treated with oral Vonoprazan 20 mg, bid + amoxicillin 1.0 g, bid + doxycycline 0.1 g, bid + bismuth for 14 days.
Vonoprazan+AmoxicillinDrug
Also called Vonoprazan+Amoxicillin Dual therapy
Group B: Patients were treated with oral Vonoprazan 20mg, bid + amoxicillin 1.0g, bid for 14 days.
Vonoprazan+doxycyclineDrug
Also called Vonoprazan+doxycycline Dual therapy
Group C: Patients were treated with oral Vonoprazan 20 mg, bid + doxycycline 0.1 g, bid for 14 days.
| Study group | Role | What they receive |
|---|---|---|
| Group A Bismuth quadruple | Active comparator | Vonoprazan 20 mg, bid + amoxicillin 1.0 g, bid + doxycycline 0.1 g, bid + bismuth, treatment course 14 days Receives: Drug: Vonoprazan+amoxicillin+doxycycline+bismuth for 14 days |
| Group B Amoxicillin Dual therapy | Experimental | Vonoprazan 20 mg, bid + amoxicillin 1.0 g, bid , treatment course 14 days Receives: Drug: Vonoprazan+Amoxicillin |
| Group C doxycycline Dual therapy | Experimental | Vonoprazan 20 mg, bid +doxycycline 0.1 g, bid，treatment course 14 days Receives: Drug: Vonoprazan+doxycycline |
What is being measured
The primary outcome is the main question the study is designed to answer.
HP eradication rate
The eradication effect of Helicobacter pylori was tested by 13C-UBT or 14C-UBT
Measured: 4-6 weeks after the end of the last dose
Secondary outcomes (1)
Patient compliance
Rate of drug consumption during the treatment period of the subjects
Measured: Within 3 days 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 posted14 May 2024
- Study start15 Jun 2024
- Primary completion1 Jan 2026
- Study completion10 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Helicobacter Pylori InfectionStudies of the same condition, open and under way.
- More trials run by Nanjing First Hospital, Nanjing Medical 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
- 579 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhenyu Zhang, Nanjing First Hospital, Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06412588
- Sponsor's protocol ID
- KY20240123-18
- Status last verified
- Mar 2026
- First submitted
- 9 May 2024
- Last updated
- 4 Mar 2026
- 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 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dual Therapy With Vonoprazan Plus Amoxicillin or Doxycycline Versus Bismuth Quadruple Therapy for Helicobacter Pylori Eradication:A Prospective, Multicenter, Open-label Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06412588
- Acronym / sponsor ID
- KY20240123-18
- Conditions
- Helicobacter Pylori Infection
- Keywords
- Helicobacter Pylori Infection, Dual therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 579 participants (actual)
- Lead sponsor
- Nanjing First Hospital, Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 15 Jun 2024 (actual)
- Primary completion
- 1 Jan 2026 (actual)
- Study completion
- 10 Jan 2026 (actual)
- First posted
- 14 May 2024 (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.
It is planned to select Hp infection patients in a number of tertiary hospitals in Jiangsu and randomly divide them into three groups: group A is the classic group, receiving Vonoprazan 20mg, bid + amoxicillin 1.0g, bid + doxycycline 0.1g, bid + colloidal pectin bismuth 0.3g, bid and group C are double groups, respectively, receiving standard dose amoxicillin (1.0 g, bid) combined with vonorrasan dual regimen and doxycycline (0.1g, bid) combined with Vonoprazan dual regimen, the treatment course of the three groups was 14 days, and the oral dose of Vonoprazan was 20mg, bid, the eradication rate, adverse reactions, compliance and other aspects of the three groups were compared, In order to obtain a safe, efficient, economical and convenient Hp eradication program with a wider range of applications.
Detailed description
It is planned to select Hp infection patients in a number of tertiary hospitals in Jiangsu and randomly divide them into three groups: group A is the classic group, receiving Vonoprazan 20mg, bid + amoxicillin 1.0g, bid + doxycycline 0.1g, bid + colloidal pectin bismuth 0.3g, bid and group C are double groups, respectively, receiving standard dose amoxicillin (1.0 g, bid) combined with vonorrasan dual regimen and doxycycline (0.1g, bid) combined with vonorrasan dual regimen, the treatment course of the three groups was 14 days, and the oral dose of Vonoprazan was 20mg, bid, the eradication rate, adverse reactions, compliance and other aspects of the three groups were compared, In order to obtain a safe, efficient, economical and convenient Hp eradication program with a wider range of applications.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A Bismuth quadruple | Active comparator | Drug: Vonoprazan+amoxicillin+doxycycline+bismuth for 14 daysVonoprazan 20 mg, bid + amoxicillin 1.0 g, bid + doxycycline 0.1 g, bid + bismuth, treatment course 14 days |
| Group B Amoxicillin Dual therapy | Experimental | Drug: Vonoprazan+AmoxicillinVonoprazan 20 mg, bid + amoxicillin 1.0 g, bid , treatment course 14 days |
| Group C doxycycline Dual therapy | Experimental | Drug: Vonoprazan+doxycyclineVonoprazan 20 mg, bid +doxycycline 0.1 g, bid，treatment course 14 days |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18-65 years old;
- Patients confirmed to be positive for H. pylori by 13C-UBT or 14C-UBT;
- Patients who have not received Helicobacter pylori eradication therapy before, or patients who have failed to eradicate in the early stage but have not received eradication therapy within half a year;
- Voluntarily join this trial and sign the informed consent form.
Key exclusion criteria (11 listed)
- Allergy to the study drug (penicillin, amoxicillin, Vonoprazan, doxycycline, etc.);
- Patients with confirmed active peptic ulcer;
- Patients who have received Helicobacter pylori eradication therapy within half a year;
- Use of antibiotics, bismuth, and histamine H2 receptor antagonists or PPIs for the first 2 weeks before starting study treatment;
- Use of adrenocorticosteroids, non-steroidal anti-inflammatory drugs, anticoagulants, barbiturates, phenytoin, or carbamazepine drugs;
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+doxycycline+bismuth for 14 daysAlso: Doxycycline-based Bismuth Quadruple TherapyGroup A:The patient was treated with oral Vonoprazan 20 mg, bid + amoxicillin 1.0 g, bid + doxycycline 0.1 g, bid + bismuth for 14 days. | Drug | Group A Bismuth quadruple |
| Vonoprazan+AmoxicillinAlso: Vonoprazan+Amoxicillin Dual therapyGroup B: Patients were treated with oral Vonoprazan 20mg, bid + amoxicillin 1.0g, bid for 14 days. | Drug | Group B Amoxicillin Dual therapy |
| Vonoprazan+doxycyclineAlso: Vonoprazan+doxycycline Dual therapyGroup C: Patients were treated with oral Vonoprazan 20 mg, bid + doxycycline 0.1 g, bid for 14 days. | Drug | Group C doxycycline Dual therapy |
Primary outcome
HP eradication rate
Time frame: 4-6 weeks after the end of the last dose
The eradication effect of Helicobacter pylori was tested by 13C-UBT or 14C-UBT
1 secondary outcome
Patient compliance
Time frame: Within 3 days after the end of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
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 Vonoprazan+amoxicillin+doxycycline+bismuth for 14 days, Vonoprazan+Amoxicillin and Vonoprazan+doxycycline in people with Helicobacter Pylori Infection, run by Nanjing First Hospital, Nanjing Medical University at 1 site in China.
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 11 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: finished, as of the sponsor's last update on 4 Mar 2026. 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 China. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
HP eradication rate (time frame: 4-6 weeks after the end of the last dose). 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 4 Mar 2026.