Helicobacter Pylori InfectionPhase 4NCT06561698
High-dose Dual Therapy and Minocycline-cotaining Quadruple Therapy for Helicobacter Pylori Infection
A Phase 4 study testing Vonoprazan, Amoxicillin and Bismuth Potassium Citrate in people with Helicobacter Pylori Infection, run by Shanghai Jiao Tong University School of Medicine at 10 sites in China.
Trial summary
This study is a multicentra, prospective study. The enrolled patients are HP positive. They are diagnosed as HP positive by rapid urease test and/or 13C urea breath test. According to the declaration of Helsinki, 200 patients will be included in this study. 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?
- Vonoprazan, Amoxicillin and Bismuth Potassium Citrate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 10 sitesChina
- Study dates
- 21 Aug 2024to 30 Aug 2026
- Phase
- Phase 4
- 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
- Ability and willingness to participate in the study and to sign and give informed consent
- Confirmed H. pylori infection
Who cannot join
- Pregnant and lactating women;
- History of gastrointestinal malignancies;
- History of previous subtotal gastrectomy;
- Serious dysfunction of heart, liver, kidney, lung and other important organs and congenital diseases; Such as grade IV cardiac insufficiency, liver failure, uremia, respiratory failure, hemophilia, Wilson disease, etc;
- History of hematological diseases
- People who are allergic to drugs;
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- The guardian or patient refused to join the group;
- Alcohol and / or drug abuse (addiction or dependence) or poor compliance judged by doctors;
- No legal capacity or poor self-knowledge
- administration of antibiotics, bismuth, antisecretory drugs, or Chinese herb medicine in the preceding 8 weeks
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
China10 sites, 10 recruiting
- Recruiting
Hebi People's Hospital
Hebi, Henan
Haiming Zhang, 18621791879, hymedical@163.com
- Recruiting
Jiaozuo People's Hospital
Jiaozuo, Henan
Xuejin Liu, 18621791879, hymedical@163.com
- Recruiting
Luoyang central Hospital
Luoyang, Henan
Hongwei Chen, 18621791879, hymedical@163.com
- Recruiting
The first people's hospital of ping ding shan
Pingdingshan, Henan
Caifeng Mi, 18621791879, hymedical@163.com
- Recruiting
Renji Hospital, School of Medicine, Shanghai Jiao Tong University
Shanghai, Shanghai Municipality, 200127
Yu Huang, Master, 86+18621791879, hymedical@163.com
Hong Lu, Ph.D
- Recruiting
Xuchang central Hospital
Xuchang, Henan
Guangwei Ding, 18621791879, hymedical@163.com
- Recruiting
The Second Affiliated Hospital of Henan University of science and technology
Zhengzhou, Henan
Zhiqiang Ma, 18621791879, hymedical@163.com
- Recruiting
The Third People's Hospital of Zhengzhou
Zhengzhou, Henan
Yi Cui, 18621791879, hymedical@163.com
- Recruiting
Zhengzhou People's Hospital
Zhengzhou, Henan
Pei Chen, 18621791879, hymedical@163.com
- Recruiting
Zhoukou Central Hospital
Zhoukou, Henan
Xuejin Liu, 18621791879, hymedical@163.com
About this study
This study is a multicentra, prospective study. The enrolled patients are HP positive. They are diagnosed as HP positive by rapid urease test and/or 13C urea breath test. According to the declaration of Helsinki, 200 patients will be included in this study. After obtaining the written informed consent of the patients, HP culture and drug sensitivity test will be conducted on all the selected patients with the success rate, adverse reactions, compliance, antibiotic resistance of HP and its impact on HP eradication.
- Conditions
- Helicobacter Pylori Infection
- Being tested
- Vonoprazan, Amoxicillin, Bismuth Potassium Citrate, Minocycline,Metronidazole
- Keywords
- Helicobacter pylori, minocycline, amoxicillin
- Medical subject headings
- cyclopia sequence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VonoprazanDrug
Potassium competitive acid blocker
AmoxicillinDrug
Antibiotics for H. pylori eradication
Bismuth Potassium CitrateDrug
Gastric mucosal protective drug with anti-H. pylori effect
Minocycline,MetronidazoleDrug
Antibiotics for H. pylori eradication
| Study group | Role | What they receive |
|---|---|---|
| Dual therapy | Experimental | Not described Receives: Drug: Vonoprazan; Drug: Amoxicillin |
| Minocycline bismush quadruple therapy | Experimental | Not described Receives: Drug: Vonoprazan; Drug: Bismuth Potassium Citrate; Drug: Minocycline,Metronidazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Helicobacter pylori eradication rate
Six weeks after completion of therapy, H. pylori eradication was assessed by ¹³C-urea breath test. Eradication was defined as negative result from urea breath test (<4‰) (4‰ as the cutoff value).
Measured: Six weeks after completion of therapy
Secondary outcomes (2)
Rate of adverse effects
The subjects were asked to grade the severity of adverse events according to their influence on daily activities, experienced as "mild" (transient and well tolerated), "moderate" (causing discomfort and partially interfering with daily activities), or "severe" (causing considerable interference with daily activities)
Measured: Within 7 days after completion of therapy
Compliance rate
Compliance was defined as poor when they had taken less than 80% of the total medication
Measured: Within 7 days after completion of therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2024
- Study start21 Aug 2024
- Primary completion30 Aug 2026 (estimated)
- Study completion30 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.
- More trials run by Shanghai Jiao Tong University School of MedicineThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hong Lu, MD, RenJi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06561698
- Sponsor's protocol ID
- rjhy20240814
- Status last verified
- Aug 2024
- First submitted
- 16 Aug 2024
- Last updated
- 30 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High-dose Dual Therapy and Minocycline-cotaining Quadruple Therapy for Helicobacter Pylori Infection
- ClinicalTrials.gov ID
- NCT06561698
- Acronym / sponsor ID
- rjhy20240814
- Conditions
- Helicobacter Pylori Infection
- Keywords
- Helicobacter pylori, minocycline, amoxicillin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 21 Aug 2024 (actual)
- Primary completion
- 30 Aug 2026 (estimated)
- Study completion
- 30 Aug 2026 (estimated)
- First posted
- 20 Aug 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.
This study is a multicentra, prospective study. The enrolled patients are HP positive. They are diagnosed as HP positive by rapid urease test and/or 13C urea breath test. According to the declaration of Helsinki, 200 patients will be included in this study. After obtaining the written informed consent of the patients, HP culture and drug sensitivity test will be conducted on all the selected patients with the success rate, adverse reactions, compliance, antibiotic resistance of HP and its impact on HP eradication.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dual therapy | Experimental | Drug: Vonoprazan, Drug: Amoxicillin |
| Minocycline bismush quadruple therapy | Experimental | Drug: Vonoprazan, Drug: Bismuth Potassium Citrate, Drug: Minocycline,Metronidazole |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Ability and willingness to participate in the study and to sign and give informed consent
- Confirmed H. pylori infection
Key exclusion criteria (10 listed)
- Pregnant and lactating women;
- History of gastrointestinal malignancies;
- History of previous subtotal gastrectomy;
- Serious dysfunction of heart, liver, kidney, lung and other important organs and congenital diseases; Such as grade IV cardiac insufficiency, liver failure, uremia, respiratory failure, hemophilia, Wilson disease, etc;
- History of hematological diseases
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 |
|---|---|---|
| VonoprazanPotassium competitive acid blocker | Drug | Dual therapy, Minocycline bismush quadruple therapy |
| AmoxicillinAntibiotics for H. pylori eradication | Drug | Dual therapy |
| Bismuth Potassium CitrateGastric mucosal protective drug with anti-H. pylori effect | Drug | Minocycline bismush quadruple therapy |
| Minocycline,MetronidazoleAntibiotics for H. pylori eradication | Drug | Minocycline bismush quadruple therapy |
Primary outcome
Helicobacter pylori eradication rate
Time frame: Six weeks after completion of therapy
Six weeks after completion of therapy, H. pylori eradication was assessed by ¹³C-urea breath test. Eradication was defined as negative result from urea breath test (<4‰) (4‰ as the cutoff value).
2 secondary outcomes
Rate of adverse effects
Time frame: Within 7 days after completion of therapy
Compliance rate
Time frame: Within 7 days after completion of therapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2024.
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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.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Vonoprazan, Amoxicillin and Bismuth Potassium Citrate in people with Helicobacter Pylori Infection, run by Shanghai Jiao Tong University School of Medicine at 10 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 2 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 30 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 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.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Helicobacter pylori eradication rate (time frame: Six weeks after completion of therapy). 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 30 Dec 2024.