Helicobacter Pylori InfectionPhase 4NCT05061732
Helicobacter Pylori Eradication and Follow-up
A Phase 4 study testing Rabeprazole, Bismuth potassium citrate and Metronidazole in people with Helicobacter Pylori Infection, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial summary
This randomized controlled clinical trial will estimate the eradication efficacy of different therapy for Helicobacter pylori treatment. The completion of this trial will expand new therapy for the treatment of Helicobacter pylori, which can not only ensure clinical efficacy, but also reduce the use of antibiotics. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Helicobacter Pylori Infection
- What is being tested?
- Rabeprazole, Bismuth potassium citrate and Metronidazole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,447 participants
- Where
- 1 siteChina
- Study dates
- 30 Sep 2021to 30 Jun 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participate in the trial voluntarily, fully understand the trial, and sign the informed consent form (ICF).
- 18-75 years old on the day of signing the ICF.
- Helicobacter pylori infection confirmed by 13C-urea breath test or rapid urease test.
Who cannot join
- Patients with severe heart, lung, kidney, liver, blood, nerve, endocrine, and psychiatric diseases.
- Subjects or guardians refused to participate in the trial.
- Alcohol and/or drugs Abuse (addiction or dependence) or poor compliance with doctor's judgment.
- Have taken antibiotics, bismuth, proton pump inhibitors or Chinese traditional medicine 4 weeks before treatment.
- Pregnant or lactating women.
- Active peptic ulcer.
- allergic to drugs used in the trial.
- any other circumstances that are not suitable for recruitment.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200032
Qi Chen, MD, 86-18817821405, chenqimd@163.com
Taotao Liu, MD
About this study
Official title: Helicobacter Pylori Eradication and Follow-up in Zhongshan Hospital
This randomized controlled clinical trial will estimate the eradication efficacy of different therapy for Helicobacter pylori treatment. The completion of this trial will expand new therapy for the treatment of Helicobacter pylori, which can not only ensure clinical efficacy, but also reduce the use of antibiotics.
- Conditions
- Helicobacter Pylori Infection
- Being tested
- Rabeprazole, Bismuth potassium citrate, Metronidazole, Clarithromycin, Levofloxacin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RabeprazoleDrug
20mg bid
Bismuth potassium citrateDrug
0.6g bid
MetronidazoleDrug
0.4g qid
ClarithromycinDrug
0.5g bid
LevofloxacinDrug
0.5g qd
AmoxicillinDrug
1g tid
MetronidazoleDrug
0.4g tid
DoxycyclineDrug
0.1g bid
TetracyclineDrug
0.5g qid
| Study group | Role | What they receive |
|---|---|---|
| RBCL | Experimental | Rabeprazole 20 mg bid, bismuth potassium citrate 0.6 g bid, clarithromycin 0.5 g bid and levofloxacin 0.5 g qd for 14 days Receives: Drug: Rabeprazole; Drug: Bismuth potassium citrate; Drug: Clarithromycin; Drug: Levofloxacin |
| RBLM | Experimental | Rabeprazole 20 mg bid, bismuth potassium citrate 0.6 g bid, metronidazole 0.4 g qid and levofloxacin 0.5 g bid for 14 days Receives: Drug: Rabeprazole; Drug: Bismuth potassium citrate; Drug: Metronidazole; Drug: Levofloxacin |
| RBCM | Experimental | Rabeprazole 20 mg bid, bismuth potassium citrate 0.6 g bid, metronidazole 0.4 g qid and clarithromycin 0.5 g bid for 14 days Receives: Drug: Rabeprazole; Drug: Bismuth potassium citrate; Drug: Metronidazole; Drug: Clarithromycin |
| RA | Experimental | Rabeprazole 20 mg bid, and Amoxicillin 1.0 g tid for 14 days Receives: Drug: Rabeprazole; Drug: Amoxicillin |
| RAB | Experimental | Rabeprazole 20 mg bid, bismuth potassium citrate 0.6 g bid, and Amoxicillin 1.0 g tid for 14 days Receives: Drug: Rabeprazole; Drug: Bismuth potassium citrate; Drug: Amoxicillin |
| RAM | Experimental | Rabeprazole 20 mg bid, metronidazole 0.4 g tid, and Amoxicillin 1.0 g tid for 14 days Receives: Drug: Rabeprazole; Drug: Metronidazole; Drug: Amoxicillin |
| RBAM | Experimental | Rabeprazole 20 mg bid, bismuth potassium citrate 0.6 g bid, metronidazole 0.4 g tid, and Amoxicillin 1.0 g tid for 14 days Receives: Drug: Rabeprazole; Drug: Bismuth potassium citrate; Drug: Metronidazole; Drug: Amoxicillin |
| RBAM4 | Experimental | Rabeprazole 20 mg bid, bismuth potassium citrate 0.6 g bid, metronidazole 0.4 g qid, and Amoxicillin 1.0 g tid for 14 days Receives: Drug: Rabeprazole; Drug: Bismuth potassium citrate; Drug: Amoxicillin; Drug: Metronidazole |
| RBDM | Experimental | Rabeprazole 20 mg bid, bismuth potassium citrate 0.6 g bid, metronidazole 0.4 g qid and doxycycline 0.1 g bid for 14 days Receives: Drug: Rabeprazole; Drug: Bismuth potassium citrate; Drug: Metronidazole; Drug: Doxycycline |
| RBTM | Active comparator | Rabeprazole 20 mg bid, bismuth potassium citrate 0.6 g bid, metronidazole 0.4 g qid, and tetracycline 0.5 g qid for 14 days Receives: Drug: Rabeprazole; Drug: Bismuth potassium citrate; Drug: Metronidazole; Drug: Tetracycline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eradication rate of Helicobacter pylori
Eradication of Helicobacter pylori was defined as negative result of urea breath test (<4‰ cut-off value).
Measured: 6 weeks
Secondary outcomes (2)
Eradication rate of Helicobacter pylori resistant strains
Eradication of Helicobacter pylori was defined as negative result of urea breath test (<4‰ cut-off value). The antibiotic resistant strains were assessed using the E test method.
Measured: 6 weeks
Eradication rate of Helicobacter pylori susceptible strains
Eradication of Helicobacter pylori was defined as negative result of urea breath test (<4‰ cut-off value). The antibiotic susceptible strains were assessed using the E test method.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2021
- Study start30 Sep 2021
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 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 Zhongshan HospitalThe 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
- 4,447 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Taotao Liu, MD, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05061732
- Sponsor's protocol ID
- B2021-376
- Status last verified
- Sep 2021
- First submitted
- 12 Sep 2021
- Last updated
- 30 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be available from the principal investigator Taotao Liu at liu.taotao@zs-hospital.sh.cn, beginning 6 months and ending 5 years after the trial results were published. The study protocol and statistical analysis plan are available online from https://clinicaltrials.gov/. All proposals requesting data access will need to specify how it is planned to use the data, and all proposals will need approval of all investigators before data release.
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Helicobacter Pylori Eradication and Follow-up in Zhongshan Hospital
- ClinicalTrials.gov ID
- NCT05061732
- Acronym / sponsor ID
- B2021-376
- Conditions
- Helicobacter Pylori Infection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 4,447 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 30 Sep 2021 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 30 Sep 2021 (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 randomized controlled clinical trial will estimate the eradication efficacy of different therapy for Helicobacter pylori treatment. The completion of this trial will expand new therapy for the treatment of Helicobacter pylori, which can not only ensure clinical efficacy, but also reduce the use of antibiotics.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| RBCL | Experimental | Drug: Rabeprazole, Drug: Bismuth potassium citrate, Drug: Clarithromycin, Drug: LevofloxacinRabeprazole 20 mg bid, bismuth potassium citrate 0.6 g bid, clarithromycin 0.5 g bid and levofloxacin 0.5 g qd for 14 days |
| RBLM | Experimental | Drug: Rabeprazole, Drug: Bismuth potassium citrate, Drug: Metronidazole, Drug: LevofloxacinRabeprazole 20 mg bid, bismuth potassium citrate 0.6 g bid, metronidazole 0.4 g qid and levofloxacin 0.5 g bid for 14 days |
| RBCM | Experimental | Drug: Rabeprazole, Drug: Bismuth potassium citrate, Drug: Metronidazole, Drug: ClarithromycinRabeprazole 20 mg bid, bismuth potassium citrate 0.6 g bid, metronidazole 0.4 g qid and clarithromycin 0.5 g bid for 14 days |
| RA | Experimental | Drug: Rabeprazole, Drug: AmoxicillinRabeprazole 20 mg bid, and Amoxicillin 1.0 g tid for 14 days |
| RAB | Experimental | Drug: Rabeprazole, Drug: Bismuth potassium citrate, Drug: AmoxicillinRabeprazole 20 mg bid, bismuth potassium citrate 0.6 g bid, and Amoxicillin 1.0 g tid for 14 days |
| RAM | Experimental | Drug: Rabeprazole, Drug: Metronidazole, Drug: AmoxicillinRabeprazole 20 mg bid, metronidazole 0.4 g tid, and Amoxicillin 1.0 g tid for 14 days |
| RBAM | Experimental | Drug: Rabeprazole, Drug: Bismuth potassium citrate, Drug: Metronidazole, Drug: AmoxicillinRabeprazole 20 mg bid, bismuth potassium citrate 0.6 g bid, metronidazole 0.4 g tid, and Amoxicillin 1.0 g tid for 14 days |
| RBAM4 | Experimental | Drug: Rabeprazole, Drug: Bismuth potassium citrate, Drug: Amoxicillin, Drug: MetronidazoleRabeprazole 20 mg bid, bismuth potassium citrate 0.6 g bid, metronidazole 0.4 g qid, and Amoxicillin 1.0 g tid for 14 days |
| RBDM | Experimental | Drug: Rabeprazole, Drug: Bismuth potassium citrate, Drug: Metronidazole, Drug: DoxycyclineRabeprazole 20 mg bid, bismuth potassium citrate 0.6 g bid, metronidazole 0.4 g qid and doxycycline 0.1 g bid for 14 days |
| RBTM | Active comparator | Drug: Rabeprazole, Drug: Bismuth potassium citrate, Drug: Metronidazole, Drug: TetracyclineRabeprazole 20 mg bid, bismuth potassium citrate 0.6 g bid, metronidazole 0.4 g qid, and tetracycline 0.5 g qid for 14 days |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Participate in the trial voluntarily, fully understand the trial, and sign the informed consent form (ICF).
- 18-75 years old on the day of signing the ICF.
- Helicobacter pylori infection confirmed by 13C-urea breath test or rapid urease test.
Key exclusion criteria (8 listed)
- Patients with severe heart, lung, kidney, liver, blood, nerve, endocrine, and psychiatric diseases.
- Subjects or guardians refused to participate in the trial.
- Alcohol and/or drugs Abuse (addiction or dependence) or poor compliance with doctor's judgment.
- Have taken antibiotics, bismuth, proton pump inhibitors or Chinese traditional medicine 4 weeks before treatment.
- Pregnant or lactating women.
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 |
|---|---|---|
| Rabeprazole20mg bid | Drug | RA, RAB, RAM, RBAM, RBAM4, RBCL, RBCM, RBDM, RBLM, RBTM |
| Bismuth potassium citrate0.6g bid | Drug | RAB, RBAM, RBAM4, RBCL, RBCM, RBDM, RBLM, RBTM |
| Metronidazole0.4g qid | Drug | RAM, RBAM, RBCM, RBLM |
| Clarithromycin0.5g bid | Drug | RBCL, RBCM |
| Levofloxacin0.5g qd | Drug | RBCL, RBLM |
| Amoxicillin1g tid | Drug | RA, RAB, RAM, RBAM, RBAM4 |
| Metronidazole0.4g tid | Drug | RBAM4, RBDM, RBTM |
| Doxycycline0.1g bid | Drug | RBDM |
| Tetracycline0.5g qid | Drug | RBTM |
Primary outcome
Eradication rate of Helicobacter pylori
Time frame: 6 weeks
Eradication of Helicobacter pylori was defined as negative result of urea breath test (<4‰ cut-off value).
2 secondary outcomes
Eradication rate of Helicobacter pylori resistant strains
Time frame: 6 weeks
Eradication rate of Helicobacter pylori susceptible strains
Time frame: 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2021.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be available from the principal investigator Taotao Liu at liu.taotao@zs-hospital.sh.cn, beginning 6 months and ending 5 years after the trial results were published. The study protocol and statistical analysis plan are available online from https://clinicaltrials.gov/. All proposals requesting data access will need to specify how it is planned to use the data, and all proposals will need approval of all investigators before data release.
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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.
Taotao Liu, MD principal investigator
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Rabeprazole, Bismuth potassium citrate and Metronidazole in people with Helicobacter Pylori Infection, run by Shanghai Zhongshan Hospital 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: status not confirmed, as of the sponsor's last update on 30 Sep 2021. 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.
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?
Contact Qi Chen, MD (86-17811921405, chenqimd@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Eradication rate of Helicobacter pylori (time frame: 6 weeks). 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 Sep 2021.