HELICOBACTER PYLORI INFECTIONSNCT07179159
Efficacy and Safety of 14-Day Vonoprazan-Based Dual Therapy Versus Quadruple Therapy for Helicobacter Pylori Eradication: A Multicentre, Non-Inferiority Randomized Controlled Trial
A study testing 14-day vonoprazan-amoxicillin dual therapy, 14-day vonoprazan-amoxicillin-levofloxacin-bismuth quadruple therapy and 14-day vonoprazan-amoxicillin-clarithromycin-bismuth quadruple therapy in people with HELICOBACTER PYLORI INFECTIONS, run by Yanqing Li at 2 sites in China.
Trial summary
This study is a multicentre, non-inferiority randomized controlled trial to compare the efficacy and safety of 14-day vonoprazan-based dual therapy with versus quadruple therapy for the eradication of Helicobacter pylori. 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?
- 14-day vonoprazan-amoxicillin dual therapy, 14-day vonoprazan-amoxicillin-levofloxacin-bismuth quadruple therapy and 14-day vonoprazan-amoxicillin-clarithromycin-bismuth quadruple therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 372 participants
- Where
- 2 sitesChina
- Study dates
- 20 Sep 2025to 30 Jun 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18-70 years, male or female
- Patients with H. pylori infection (positive 13C-urea breath test, together with at least one positive result from the following three tests: (a) stool H. pylori antigen test; (b) rapid urease test; (c) histopathological examination of gastric mucosal biopsy tissue)
- No prior Helicobacter pylori eradication therapy
Who cannot join
- Severe underlying conditions, such as hepatic insufficiency, renal insufficiency, malignant tumours
- Active gastrointestinal bleeding
- History of upper gastrointestinal surgery
- History of drug hypersensitivity
- Use of bismuth compounds or antibiotics within the past 4 weeks, or acid-suppressing agents within the past 2 weeks
- Pregnant or lactating women
- Presence of other risk-increasing behaviours such as alcohol abuse or illicit drug use
- Individuals unable or unwilling to provide informed consent
Trial locations and contacts
2 sites in 1 country.
China2 sites
Qilu Hospital of Shandong University
Jinan, Shandong, 250012
Qilu Hospital of Shandong University
Jinan
About this study
This study is a multicentre, non-inferiority randomized controlled trial to compare the efficacy and safety of 14-day vonoprazan-based dual therapy with versus quadruple therapy for the eradication of Helicobacter pylori. The primary outcome is eradication rate, and the secondary outcome includes the incidence of adverse events and compliance.
- Conditions
- HELICOBACTER PYLORI INFECTIONS
- Being tested
- 14-day vonoprazan-amoxicillin dual therapy, 14-day vonoprazan-amoxicillin-levofloxacin-bismuth quadruple therapy, 14-day vonoprazan-amoxicillin-clarithromycin-bismuth quadruple therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
14-day vonoprazan-amoxicillin dual therapyDrug
vonoprazan 20mg bid + amoxicillin 1000mg bid
14-day vonoprazan-amoxicillin-levofloxacin-bismuth quadruple therapyDrug
vonoprazan 20mg bid + amoxicillin 1000mg bid + levofloxacin 500mg qd + bismuth 220mg bid
14-day vonoprazan-amoxicillin-clarithromycin-bismuth quadruple therapyDrug
vonoprazan 20mg bid + amoxicillin 1000mg bid + clarithromycin 500mg bid + bismuth 220mg bid
| Study group | Role | What they receive |
|---|---|---|
| 14-day vonoprazan-amoxicillin dual therapy | Experimental | Not described Receives: Drug: 14-day vonoprazan-amoxicillin dual therapy |
| 14-day vonoprazan-amoxicillin-levofloxacin-bismuth quadruple therapy | Active comparator | Not described Receives: Drug: 14-day vonoprazan-amoxicillin-levofloxacin-bismuth quadruple therapy |
| 14-day vonoprazan-amoxicillin-clarithromycin-bismuth quadruple therapy | Active comparator | Not described Receives: Drug: 14-day vonoprazan-amoxicillin-clarithromycin-bismuth quadruple therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
eradication rate
Measured: 6 weeks after treatment
Secondary outcomes (2)
adverse events
Measured: immediately after a 2-week treatment
compliance
Satisfactory compliance was defined as taking medications with at least 80% of the prescribed dosage. The proportion of patients with satisfactory compliance was calculated among all patients.
Measured: immediately after a 2-week treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2025
- Study start20 Sep 2025
- Primary completion30 Jun 2026
- Study completion30 Jun 2026
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 372 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yanqing Li
- Sponsor type
- University, hospital or other
- Collaborators
- Longkou People's Hospital, Qingdao Jimo People's Hospital, Shandong University of Traditional Chinese Medicine, Dezhou Hospital Qilu Hospital of Shandong University, Zibo Maternal and Child Health Hospital, Guanxian County People's Hospital, Yantai Zhifu Hospital, Dongying No. 2 People's Hospital, Qilu Hospital of Shandong University
- Responsible party
- Sponsor-investigator, Yanqing Li, Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07179159
- Sponsor's protocol ID
- 202509
- Status last verified
- Aug 2025
- First submitted
- 30 Aug 2025
- Last updated
- 23 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of 14-Day Vonoprazan-Based Dual Therapy Versus Quadruple Therapy for Helicobacter Pylori Eradication: A Multicentre, Non-Inferiority Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07179159
- Acronym / sponsor ID
- 202509
- Conditions
- HELICOBACTER PYLORI INFECTIONS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 372 participants (actual)
- Lead sponsor
- Yanqing LiUniversity, hospital or other
- Collaborators
- Longkou People's Hospital, Qingdao Jimo People's Hospital, Shandong University of Traditional Chinese Medicine, Dezhou Hospital Qilu Hospital of Shandong University, Zibo Maternal and Child Health Hospital, Guanxian County People's Hospital, Yantai Zhifu Hospital, Dongying No. 2 People's Hospital, Qilu Hospital of Shandong University
- Study start
- 20 Sep 2025 (actual)
- Primary completion
- 30 Jun 2026 (actual)
- Study completion
- 30 Jun 2026 (actual)
- First posted
- 17 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 is a multicentre, non-inferiority randomized controlled trial to compare the efficacy and safety of 14-day vonoprazan-based dual therapy with versus quadruple therapy for the eradication of Helicobacter pylori. The primary outcome is eradication rate, and the secondary outcome includes the incidence of adverse events and compliance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 14-day vonoprazan-amoxicillin dual therapy | Experimental | Drug: 14-day vonoprazan-amoxicillin dual therapy |
| 14-day vonoprazan-amoxicillin-levofloxacin-bismuth quadruple therapy | Active comparator | Drug: 14-day vonoprazan-amoxicillin-levofloxacin-bismuth quadruple therapy |
| 14-day vonoprazan-amoxicillin-clarithromycin-bismuth quadruple therapy | Active comparator | Drug: 14-day vonoprazan-amoxicillin-clarithromycin-bismuth quadruple therapy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged 18-70 years, male or female
- Patients with H. pylori infection (positive 13C-urea breath test, together with at least one positive result from the following three tests: (a) stool H. pylori antigen test; (b) rapid urease test; (c) histopathological examination of gastric mucosal biopsy tissue)
- No prior Helicobacter pylori eradication therapy
Key exclusion criteria (8 listed)
- Severe underlying conditions, such as hepatic insufficiency, renal insufficiency, malignant tumours
- Active gastrointestinal bleeding
- History of upper gastrointestinal surgery
- History of drug hypersensitivity
- Use of bismuth compounds or antibiotics within the past 4 weeks, or acid-suppressing agents within the past 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 |
|---|---|---|
| 14-day vonoprazan-amoxicillin dual therapyvonoprazan 20mg bid + amoxicillin 1000mg bid | Drug | 14-day vonoprazan-amoxicillin dual therapy |
| 14-day vonoprazan-amoxicillin-levofloxacin-bismuth quadruple therapyvonoprazan 20mg bid + amoxicillin 1000mg bid + levofloxacin 500mg qd + bismuth 220mg bid | Drug | 14-day vonoprazan-amoxicillin-levofloxacin-bismuth quadruple therapy |
| 14-day vonoprazan-amoxicillin-clarithromycin-bismuth quadruple therapyvonoprazan 20mg bid + amoxicillin 1000mg bid + clarithromycin 500mg bid + bismuth 220mg bid | Drug | 14-day vonoprazan-amoxicillin-clarithromycin-bismuth quadruple therapy |
Primary outcome
eradication rate
Time frame: 6 weeks after treatment
2 secondary outcomes
adverse events
Time frame: immediately after a 2-week treatment
compliance
Time frame: immediately after a 2-week 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 23 Oct 2026.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 14-day vonoprazan-amoxicillin dual therapy, 14-day vonoprazan-amoxicillin-levofloxacin-bismuth quadruple therapy and 14-day vonoprazan-amoxicillin-clarithromycin-bismuth quadruple therapy in people with HELICOBACTER PYLORI INFECTIONS, run by Yanqing Li at 2 sites 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 23 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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: 6 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 23 Oct 2026.