HELICOBACTER PYLORI INFECTIONSPSMNCT07333001
Efficacy and Safety of 7-day Triple Therapy Containing Amoxicillin and Tetracycline Versus 14-day Dual Therapy for Helicobacter Pylori Eradication
An observational study of HELICOBACTER PYLORI INFECTIONS, run by Yueyue Li at 1 site in China.
Trial summary
With the increasing prevalence of antibiotic resistance, the clinical efficacy of conventional 7-day triple therapy for Helicobacter pylori eradication has been substantially diminished. However, the efficacy and safety of a 7-day triple regimen based on amoxicillin and tetracycline warrant further investigation. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- HELICOBACTER PYLORI INFECTIONS
- What is being tested?
- 7-day triple therapy and 14-day dual therapy
- How many people
- 508 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2025to 27 Dec 2025
- Phase
- Observational
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: * patients aged 18-70 years; * patients with H. pylori infection confirmed by 13C/14C-urea breath test or rapid urease test; * patients with no history of H. pylori eradication therapy
Who may be able to join
- patients aged 18-70 years;
- patients with H. pylori infection confirmed by 13C/14C-urea breath test or rapid urease test;
- patients with no history of H. pylori eradication therapy
Who cannot join
- patients with severe underlying diseases, such as hepatic insufficiency, renal insufficiency, immunosuppression, malignant tumors, and coronary heart disease;
- patients with active gastrointestinal bleeding;
- patients with a history of upper gastrointestinal surgery;
- patients allergic to treatment drugs;
- patients with medication history of bismuth, antibiotics within 4 weeks, or proton pump inhibitors within 2 weeks;
- patients who were pregnant or lactating or unwilling to take contraceptive measures during the trial;
- patients with other behaviors that may increase the risk of disease, such as alcohol and drug abuse;
- incomplete data.
Trial locations and contacts
1 site in 1 country.
About this study
With the increasing prevalence of antibiotic resistance, the clinical efficacy of conventional 7-day triple therapy for Helicobacter pylori eradication has been substantially diminished. However, the efficacy and safety of a 7-day triple regimen based on amoxicillin and tetracycline warrant further investigation. This retrospective study was designed to compare the efficacy and safety of a 7-day triple therapy based on amoxicillin and tetracycline combination versus the standard 14-day high-dose dual therapy for H. pylori infection. Data on therapies for H. pylori eradication were extracted between January 2023 and October 2025 at Qilu Hospital of Shandong University. Two regimens were compared based on 1:3 propensity score matching: 7-day triple therapy (vonoprazan 20 mg twice daily, amoxicillin 1000 mg twice daily, and tetracycline 500 mg four times daily) and 14-day high-dose dual therapy (vonoprazan 20 mg twice daily and amoxicillin 1000 mg three times daily). Eradication rates and incidence of adverse events were assessed.
- Conditions
- HELICOBACTER PYLORI INFECTIONS
- Being tested
- 7-day triple therapy, 14-day dual therapy
- Keywords
- Helicobacter pylori, triple therapy, dual therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
7-day triple therapyDrug
vonoprazan 20 mg twice daily, amoxicillin 1000 mg twice daily, and tetracycline 500 mg four times daily for 7 days
14-day dual therapyDrug
vonoprazan 20 mg twice daily and amoxicillin 1000 mg three times daily for 14 days
| Study group | Role | What they receive |
|---|---|---|
| triple therapy | Not described Receives: Drug: 7-day triple therapy | |
| dual therapy | Not described Receives: Drug: 14-day dual therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
eradication rate
Measured: six weeks after treatment
Secondary outcomes (1)
incidence of adverse events
Measured: immediately after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2026
- Study start1 Nov 2025
- Primary completion15 Dec 2025
- Study completion27 Dec 2025
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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 508 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yueyue Li
- Sponsor type
- University, hospital or other
- Collaborators
- Qilu Hospital of Shandong University
- Responsible party
- Sponsor-investigator, Yueyue Li, Qilu Hospital of Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07333001
- Sponsor's protocol ID
- 202512
- Acronym
- PSM
- Status last verified
- Dec 2025
- First submitted
- 27 Dec 2025
- Last updated
- 12 Jan 2026
- Results posted
- 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 12 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of 7-day Triple Therapy Containing Amoxicillin and Tetracycline Versus 14-day Dual Therapy for Helicobacter Pylori Eradication
- ClinicalTrials.gov ID
- NCT07333001
- Acronym / sponsor ID
- PSM / 202512
- Conditions
- HELICOBACTER PYLORI INFECTIONS
- Keywords
- Helicobacter pylori, triple therapy, dual therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 508 participants (actual)
- Lead sponsor
- Yueyue LiUniversity, hospital or other
- Collaborators
- Qilu Hospital of Shandong University
- Study start
- 1 Nov 2025 (actual)
- Primary completion
- 15 Dec 2025 (actual)
- Study completion
- 27 Dec 2025 (actual)
- First posted
- 12 Jan 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.
With the increasing prevalence of antibiotic resistance, the clinical efficacy of conventional 7-day triple therapy for Helicobacter pylori eradication has been substantially diminished. However, the efficacy and safety of a 7-day triple regimen based on amoxicillin and tetracycline warrant further investigation. This retrospective study was designed to compare the efficacy and safety of a 7-day triple therapy based on amoxicillin and tetracycline combination versus the standard 14-day high-dose dual therapy for H. pylori infection. Data on therapies for H. pylori eradication were extracted between January 2023 and October 2025 at Qilu Hospital of Shandong University. Two regimens were compared based on 1:3 propensity score matching: 7-day triple therapy (vonoprazan 20 mg twice daily, amoxicillin 1000 mg twice daily, and tetracycline 500 mg four times daily) and 14-day high-dose dual therapy (vonoprazan 20 mg twice daily and amoxicillin 1000 mg three times daily). Eradication rates and incidence of adverse events were assessed.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| triple therapy | – | Drug: 7-day triple therapy |
| dual therapy | – | Drug: 14-day dual therapy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- * patients aged 18-70 years; * patients with H. pylori infection confirmed by 13C/14C-urea breath test or rapid urease test; * patients with no history of H. pylori eradication therapy
Key inclusion criteria (3 listed)
- patients aged 18-70 years;
- patients with H. pylori infection confirmed by 13C/14C-urea breath test or rapid urease test;
- patients with no history of H. pylori eradication therapy
Key exclusion criteria (8 listed)
- patients with severe underlying diseases, such as hepatic insufficiency, renal insufficiency, immunosuppression, malignant tumors, and coronary heart disease;
- patients with active gastrointestinal bleeding;
- patients with a history of upper gastrointestinal surgery;
- patients allergic to treatment drugs;
- patients with medication history of bismuth, antibiotics within 4 weeks, or proton pump inhibitors 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 |
|---|---|---|
| 7-day triple therapyvonoprazan 20 mg twice daily, amoxicillin 1000 mg twice daily, and tetracycline 500 mg four times daily for 7 days | Drug | triple therapy |
| 14-day dual therapyvonoprazan 20 mg twice daily and amoxicillin 1000 mg three times daily for 14 days | Drug | dual therapy |
Primary outcome
eradication rate
Time frame: six weeks after treatment
1 secondary outcome
incidence of adverse events
Time frame: immediately after 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 12 Jan 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?
An observational study of HELICOBACTER PYLORI INFECTIONS, run by Yueyue Li 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 3 inclusion and 8 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 12 Jan 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?
eradication rate (time frame: six weeks after 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 12 Jan 2026.