Helicobacter Pylori InfectionPRO-HPNCT07285096
P-CABs-based Bismuth Quadruple Therapy for Helicobacter Pylori Eradication
An observational study of Helicobacter Pylori Infection, run by Yueyue Li at 1 site in China.
Trial summary
Bismuth-containing quadruple therapy was recommended as a first-line treatment for Helicobacter pylori infection. This study aimed to compare real-world outcomes of various potassium-competitive acid blockers (P-CABs) -based bismuth quadruple regimens and identify factors influencing treatment failure. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Helicobacter Pylori Infection
- What is being tested?
- Doctors prescribe Helicobacter pylori treatment regimens for patients based on current guidelines and consensus statements, tailored to individual circumstances，not involve any intervention procedures
- How many people
- 1,730 participants
- Where
- 1 siteChina
- Study dates
- 16 Dec 2025to 1 Aug 2026
- How long will I take part?
- 8 Weeks
- Phase
- Observational
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: (1) patients aged 18-70 years, regardless of gender; (2) willing to receive H. pylori eradication therapy; (3) diagnosed with H. pylori infection through at least one of the following methods: rapid urease test, ¹³C/¹⁴C-urea breath test, or histopathological examination.
Who may be able to join
- patients aged 18-70 years, regardless of gender;
- willing to receive H. pylori eradication therapy;
- diagnosed with H. pylori infection through at least one of the following methods: rapid urease test, ¹³C/¹⁴C-urea breath test, or histopathological examination.
Who cannot join
- patients with incomplete medical records, including missing treatment details, absence of post-treatment follow-up test results, or failure to complete essential follow-up assessments;
- patients who received treatment regimens that did not comply with the quadruple regimens specified in this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Qilu Hospital of Shandong University
Jinan
Yueyue Li, +8618560089751, lyynqj@126.com
About this study
Official title: Efficacy and Safety of P-CABs-Based Bismuth Quadruple Therapy for First-line Helicobacter Pylori Eradication: A Multicenter Cohort Study
Bismuth-containing quadruple therapy was recommended as a first-line treatment for Helicobacter pylori infection. This study aimed to compare real-world outcomes of various potassium-competitive acid blockers (P-CABs) -based bismuth quadruple regimens and identify factors influencing treatment failure. A multicenter cohort study was conducted and study outcomes included eradication rates and incidence of adverse events.
- Conditions
- Helicobacter Pylori Infection
- Being tested
- Doctors prescribe Helicobacter pylori treatment regimens for patients based on current guidelines and consensus statements, tailored to individual circumstances，not involve any intervention procedures
- Keywords
- Helicobacter pylori, quadruple therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Doctors prescribe Helicobacter pylori treatment regimens for patients based on current guidelines and consensus statements, tailored to individual circumstances，not involve any intervention proceduresOther
Doctors prescribe Helicobacter pylori treatment regimens for patients based on current guidelines and consensus statements, tailored to individual circumstances，not involve any intervention procedures.
| Study group | Role | What they receive |
|---|---|---|
| vonoprazan-based quadruple therapies | Not described Receives: Other: Doctors prescribe Helicobacter pylori treatment regimens for patients based on current guidelines and consensus statements, tailored to individual circumstances，not involve any intervention procedures | |
| tegoprazan-based quadruple therapies | Not described Receives: Other: Doctors prescribe Helicobacter pylori treatment regimens for patients based on current guidelines and consensus statements, tailored to individual circumstances，not involve any intervention procedures |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eradication rate
Comparison of eradication rates among quadruple therapies for Helicobacter pylori
Measured: 6-8 weeks after treatment completion
Secondary outcomes (1)
Adverse events
Measured: lmmediately after treatment completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2025
- Study start16 Dec 2025
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Aug 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 InfectionStudies 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
- Prospective
- Enrolment
- 1,730 participants (estimated)
- Target duration
- 8 Weeks
Sponsor and investigators
- Lead sponsor
- Yueyue Li
- Sponsor type
- University, hospital or other
- Collaborators
- Qilu Hospital of Shandong University, Feicheng People's Hospital, Binzhou Maternal and Child Health Hospital, Jinxiang County People's Hospital, The People's Hospital of Jimo, Zibo Maternal and Child Health Hospital, Yantai Penglai Traditional Chinese Medicine Hospital, Zaozhuang Municipal Hospital, Linyi People's Hospital, Taierzhuang District People's Hospital, Shandong University of Traditional Chinese Medicine, Yuncheng Traditional Chinese Medicine Hospital, Caoxian County Hospital, Qihe County People's Hospital, Affiliated Hospital of Shandong University of Traditional Chinese Medicine, Dezhou Hospital Qilu Hospital of Shandong University, Dongying No. 2 People's Hospital, Zhangdian District Hospital of Traditional Chinese Medicine, Yantai Zhifu Hospital, Inner Mongolia People's Hospital, Hohhot Second Hospital, Guanxian County People's Hospital, Longkou People's Hospital, Linshu County Hospital of Traditional Chinese Medicine
- Responsible party
- Sponsor-investigator, Yueyue Li, Qilu Hospital of Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07285096
- Sponsor's protocol ID
- 202511
- Acronym
- PRO-HP
- Status last verified
- Dec 2025
- First submitted
- 27 Nov 2025
- Last updated
- 23 Dec 2025
- 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 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of P-CABs-Based Bismuth Quadruple Therapy for First-line Helicobacter Pylori Eradication: A Multicenter Cohort Study
- ClinicalTrials.gov ID
- NCT07285096
- Acronym / sponsor ID
- PRO-HP / 202511
- Conditions
- Helicobacter Pylori Infection
- Keywords
- Helicobacter pylori, quadruple therapy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,730 participants (estimated)
- Lead sponsor
- Yueyue LiUniversity, hospital or other
- Collaborators
- Qilu Hospital of Shandong University, Feicheng People's Hospital, Binzhou Maternal and Child Health Hospital, Jinxiang County People's Hospital, The People's Hospital of Jimo, Zibo Maternal and Child Health Hospital, Yantai Penglai Traditional Chinese Medicine Hospital, Zaozhuang Municipal Hospital, Linyi People's Hospital, Taierzhuang District People's Hospital, Shandong University of Traditional Chinese Medicine, Yuncheng Traditional Chinese Medicine Hospital, Caoxian County Hospital, Qihe County People's Hospital, Affiliated Hospital of Shandong University of Traditional Chinese Medicine, Dezhou Hospital Qilu Hospital of Shandong University, Dongying No. 2 People's Hospital, Zhangdian District Hospital of Traditional Chinese Medicine, Yantai Zhifu Hospital, Inner Mongolia People's Hospital, Hohhot Second Hospital, Guanxian County People's Hospital, Longkou People's Hospital, Linshu County Hospital of Traditional Chinese Medicine
- Study start
- 16 Dec 2025 (actual)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Aug 2026 (estimated)
- First posted
- 16 Dec 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.
Bismuth-containing quadruple therapy was recommended as a first-line treatment for Helicobacter pylori infection. This study aimed to compare real-world outcomes of various potassium-competitive acid blockers (P-CABs) -based bismuth quadruple regimens and identify factors influencing treatment failure. A multicenter cohort study was conducted and study outcomes included eradication rates and incidence of adverse events.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 8 Weeks
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| vonoprazan-based quadruple therapies | – | Other: Doctors prescribe Helicobacter pylori treatment regimens for patients based on current guidelines and consensus statements, tailored to individual circumstances，not involve any intervention procedures |
| tegoprazan-based quadruple therapies | – | Other: Doctors prescribe Helicobacter pylori treatment regimens for patients based on current guidelines and consensus statements, tailored to individual circumstances，not involve any intervention procedures |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- (1) patients aged 18-70 years, regardless of gender; (2) willing to receive H. pylori eradication therapy; (3) diagnosed with H. pylori infection through at least one of the following methods: rapid urease test, ¹³C/¹⁴C-urea breath test, or histopathological examination.
Key inclusion criteria (3 listed)
- patients aged 18-70 years, regardless of gender;
- willing to receive H. pylori eradication therapy;
- diagnosed with H. pylori infection through at least one of the following methods: rapid urease test, ¹³C/¹⁴C-urea breath test, or histopathological examination.
Key exclusion criteria (2 listed)
- patients with incomplete medical records, including missing treatment details, absence of post-treatment follow-up test results, or failure to complete essential follow-up assessments;
- patients who received treatment regimens that did not comply with the quadruple regimens specified in this study.
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 |
|---|---|---|
| Doctors prescribe Helicobacter pylori treatment regimens for patients based on current guidelines and consensus statements, tailored to individual circumstances，not involve any intervention proceduresDoctors prescribe Helicobacter pylori treatment regimens for patients based on current guidelines and consensus statements, tailored to individual circumstances，not involve any intervention procedures. | Other | tegoprazan-based quadruple therapies, vonoprazan-based quadruple therapies |
Primary outcome
Eradication rate
Time frame: 6-8 weeks after treatment completion
Comparison of eradication rates among quadruple therapies for Helicobacter pylori
1 secondary outcome
Adverse events
Time frame: lmmediately after treatment completion
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 23 Dec 2025.
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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.
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 Infection, 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 2 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: looking for participants now, as of the sponsor's last update on 23 Dec 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 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?
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 Yueyue Li (+8618560089751, lyynqj@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Eradication rate (time frame: 6-8 weeks after treatment completion). 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 Dec 2025.