Helicobacter Pylori InfectionPhase 4NCT05014685
PPI-amoxicillin for H. Pylori Treatment
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 identify the additional benefit of bismuth or metronidazole in proton pump inhibitor-amoxicillin-containing therapy for Helicobacter pylori first-line treatment. 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
- 732 participants
- Where
- 1 siteChina
- Study dates
- 20 Aug 2021to 30 Dec 2022
- 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.
- Have not received Helicobacter pylori eradication treatment before.
Who cannot join
- Have received Hp eradication treatment.
- 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, PPI or Chinese traditional medicine 4 weeks before treatment.
- Pregnant or lactating women.
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- 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: Proton Pump Inhibitor and Amoxicillin Combined Bismuth or Metronidazole for Helicobacter Pylori First-line Treatment: A Randomized Controlled Trial
This randomized controlled clinical trial will identify the additional benefit of bismuth or metronidazole in proton pump inhibitor-amoxicillin-containing therapy for Helicobacter pylori first-line 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, Amoxicillin
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 tid
AmoxicillinDrug
1g tid
| Study group | Role | What they receive |
|---|---|---|
| RA group | Experimental | Not described Receives: Drug: Rabeprazole; Drug: Amoxicillin |
| RAM group | Experimental | Not described Receives: Drug: Rabeprazole; Drug: Metronidazole; Drug: Amoxicillin |
| RAB group | Experimental | Not described Receives: Drug: Rabeprazole; Drug: Bismuth potassium citrate; Drug: Amoxicillin |
| RABM group | Active comparator | Not described Receives: Drug: Rabeprazole; Drug: Bismuth potassium citrate; Drug: Metronidazole; Drug: Amoxicillin |
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: At least 4 weeks after completion of therapy
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: At least 4 weeks after completion of therapy
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: At least 4 weeks 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 2021
- Study start20 Aug 2021
- Primary completion30 Dec 2022 (estimated)
- Study completion30 Dec 2022 (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
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 732 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
- NCT05014685
- Sponsor's protocol ID
- B2021-3761
- Status last verified
- Aug 2021
- First submitted
- 13 Aug 2021
- Last updated
- 23 Aug 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 23 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proton Pump Inhibitor and Amoxicillin Combined Bismuth or Metronidazole for Helicobacter Pylori First-line Treatment: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05014685
- Acronym / sponsor ID
- B2021-3761
- Conditions
- Helicobacter Pylori Infection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 732 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 20 Aug 2021 (actual)
- Primary completion
- 30 Dec 2022 (estimated)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 20 Aug 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 identify the additional benefit of bismuth or metronidazole in proton pump inhibitor-amoxicillin-containing therapy for Helicobacter pylori first-line 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
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| RA group | Experimental | Drug: Rabeprazole, Drug: Amoxicillin |
| RAM group | Experimental | Drug: Rabeprazole, Drug: Metronidazole, Drug: Amoxicillin |
| RAB group | Experimental | Drug: Rabeprazole, Drug: Bismuth potassium citrate, Drug: Amoxicillin |
| RABM group | Active comparator | Drug: Rabeprazole, Drug: Bismuth potassium citrate, Drug: Metronidazole, Drug: Amoxicillin |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 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.
- Have not received Helicobacter pylori eradication treatment before.
Key exclusion criteria (9 listed)
- Have received Hp eradication treatment.
- 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, PPI or Chinese traditional medicine 4 weeks before treatment.
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 group, RAB group, RABM group, RAM group |
| Bismuth potassium citrate0.6g bid | Drug | RAB group, RABM group |
| Metronidazole0.4g tid | Drug | RABM group, RAM group |
| Amoxicillin1g tid | Drug | RA group, RAB group, RABM group, RAM group |
Primary outcome
Eradication rate of Helicobacter pylori
Time frame: At least 4 weeks after completion of therapy
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: At least 4 weeks after completion of therapy
Eradication rate of Helicobacter pylori susceptible strains
Time frame: At least 4 weeks 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 23 Aug 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 4 inclusion and 9 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 23 Aug 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: At least 4 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 23 Aug 2021.