Helicobacter Pylori EradicationPhase 4NCT04558502
Effectiveness of Minocycline-Containing Bismuth Quadruple Therapy for Helicobacter Pylori Eradication
A Phase 4 study testing Minocycline hydrochloride capsule, Clarithromycin and Amoxicillin in people with Helicobacter Pylori Eradication, run by Second Affiliated Hospital, Zhejiang University, School of Medicine.
Trial summary
Although,bismuth-containing quadruple therapy has been highly recommended as first-line treatment regimen for H.pylori infection,it also has its problems and limitations in China.The primary resistance rates of metronidazole,clarithromycin and levofloxacin are all high in China.Besides that,tetracycline cannot be… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Helicobacter Pylori Eradication
- What is being tested?
- Minocycline hydrochloride capsule, Clarithromycin and Amoxicillin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 339 participants
- Where
- No sites listed yet
- Study dates
- 5 Jan 2022to 5 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- H.pylori-positive outpatients with endoscopically proven chronic gastritis
- H. pylori (+) determined by either the 14C-or 13C-urea breath test or the gastric mucosal tissue rapid urease test and pathological section staining
- Treatment-naive patients for eradication of H.pylori infection
- Fully informed and agreed to participate in this study
Who cannot join
- Age <18 years or >70 years
- Allergy to any of the study drugs
- Use of any drug that could influence the study results 4 weeks before the study,such as antibiotics,bismuth agent,PPI or H2 receptor antagonist (H2RA)
- Previous gastric or esophageal surgery
- Patients with malignancy or severe comorbidity
- Pregnancy,lactation or alcohol abuse
- Patients with poor treatment compliance or could not express themselves correctly
- Participation in other clinical studies recently (within 3 months of enrollment in this clinical study)
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effectiveness of Minocycline-Containing Bismuth Quadruple Therapy as First-Line Regimen for Helicobacter Pylori Eradication
Although,bismuth-containing quadruple therapy has been highly recommended as first-line treatment regimen for H.pylori infection,it also has its problems and limitations in China.The primary resistance rates of metronidazole,clarithromycin and levofloxacin are all high in China.Besides that,tetracycline cannot be obtained and its complicated administration (four times daily) easily reduce patient compliance. In this study, we proposed to evaluate the eradication rate, safety, and compliance of a minocycline-based bismuth quadruple regimen.
Read the detailed description
A total of 339 H. pylori-infected, treatment-naive patients will be enrolled in this randomized controlled clinical trial. Patients will be randomly allocated into 3 groups: Esomeprazole 20 mg, clarithromycin 500 mg, amoxicillin 1000 mg, and colloidal bismuth pectin 200 mg twice daily for 14 days; Esomeprazole 20 mg, minocycline 100 mg, amoxicillin 1000 mg, and colloidal bismuth pectin 200 mg twice daily for 14 days; Esomeprazole 20 mg, minocycline 100 mg, amoxicillin 1000 mg, and colloidal bismuth pectin 200 mg twice daily for 10 days. Eradication rates will be assessed 4-12 weeks after treatment.
- Conditions
- Helicobacter Pylori Eradication
- Being tested
- Minocycline hydrochloride capsule, Clarithromycin, Amoxicillin, colloidal bismuth pectin, esomeprazole
- Keywords
- Helicobacter pylori, Eradication, minocycline, bismuth quadruple regimens
- Medical subject headings
- cyclopia sequence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Minocycline hydrochloride capsuleDrug
Also called Meiman
Antibiotic for H. pylori eradication
ClarithromycinDrug
Also called Klacid
Antibiotic for H. pylori eradication
AmoxicillinDrug
Antibiotic for H. pylori eradication
colloidal bismuth pectinDrug
Gastric mucosal protective drug with anti-H. pylori effect
esomeprazoleDrug
Proton pump inhibitor
| Study group | Role | What they receive |
|---|---|---|
| minocycline-based bismuth quadruple regimen for 14 days | Experimental | Esomeprazole 20 mg, minocycline 100 mg, amoxicillin 1000 mg, and colloidal bismuth pectin 200 mg twice daily for 14 days. Receives: Drug: Minocycline hydrochloride capsule; Drug: Amoxicillin; Drug: colloidal bismuth pectin; Drug: esomeprazole |
| clarithromycin-based bismuth quadruple regimen for 14 days | Active comparator | Esomeprazole 20 mg,clarithromycin 500 mg, amoxicillin 1000 mg, and colloidal bismuth pectin 200 mg twice daily for 14 days. Receives: Drug: Clarithromycin; Drug: Amoxicillin; Drug: colloidal bismuth pectin; Drug: esomeprazole |
| minocycline-based bismuth quadruple regimen for 10 days | Experimental | Esomeprazole 20 mg, minocycline 100 mg, amoxicillin 1000 mg, and colloidal bismuth pectin 200 mg twice daily for 10 days. Receives: Drug: Minocycline hydrochloride capsule; Drug: Amoxicillin; Drug: colloidal bismuth pectin; Drug: esomeprazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eradication rate
Helicobacter pylori eradication of minocycline-containing bismuth quadruple therapy
Measured: 4-12 weeks after treatment
Secondary outcomes (1)
incidence of adverse effects
incidence of adverse effects of minocycline-containing bismuth quadruple therapy
Measured: 3-7 days after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2020
- Study start5 Jan 2022 (estimated)
- Primary completion5 Jun 2022 (estimated)
- Study completion5 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 EradicationStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 339 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Qin Du, master, Principal investigator, 2nd Affiliated Hospital,School of Medicine,Zhejiang University,China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04558502
- Sponsor's protocol ID
- 2020-584
- Status last verified
- Dec 2021
- First submitted
- 15 Sep 2020
- Last updated
- 13 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Minocycline-Containing Bismuth Quadruple Therapy as First-Line Regimen for Helicobacter Pylori Eradication
- ClinicalTrials.gov ID
- NCT04558502
- Acronym / sponsor ID
- 2020-584
- Conditions
- Helicobacter Pylori Eradication
- Keywords
- Helicobacter pylori, Eradication, minocycline, bismuth quadruple regimens
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 339 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 5 Jan 2022 (estimated)
- Primary completion
- 5 Jun 2022 (estimated)
- Study completion
- 5 Dec 2022 (estimated)
- First posted
- 22 Sep 2020 (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.
Although,bismuth-containing quadruple therapy has been highly recommended as first-line treatment regimen for H.pylori infection,it also has its problems and limitations in China.The primary resistance rates of metronidazole,clarithromycin and levofloxacin are all high in China.Besides that,tetracycline cannot be obtained and its complicated administration (four times daily) easily reduce patient compliance. In this study, we proposed to evaluate the eradication rate, safety, and compliance of a minocycline-based bismuth quadruple regimen.
Detailed description
A total of 339 H. pylori-infected, treatment-naive patients will be enrolled in this randomized controlled clinical trial. Patients will be randomly allocated into 3 groups: Esomeprazole 20 mg, clarithromycin 500 mg, amoxicillin 1000 mg, and colloidal bismuth pectin 200 mg twice daily for 14 days; Esomeprazole 20 mg, minocycline 100 mg, amoxicillin 1000 mg, and colloidal bismuth pectin 200 mg twice daily for 14 days; Esomeprazole 20 mg, minocycline 100 mg, amoxicillin 1000 mg, and colloidal bismuth pectin 200 mg twice daily for 10 days. Eradication rates will be assessed 4-12 weeks after treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| minocycline-based bismuth quadruple regimen for 14 days | Experimental | Drug: Minocycline hydrochloride capsule, Drug: Amoxicillin, Drug: colloidal bismuth pectin, Drug: esomeprazoleEsomeprazole 20 mg, minocycline 100 mg, amoxicillin 1000 mg, and colloidal bismuth pectin 200 mg twice daily for 14 days. |
| clarithromycin-based bismuth quadruple regimen for 14 days | Active comparator | Drug: Clarithromycin, Drug: Amoxicillin, Drug: colloidal bismuth pectin, Drug: esomeprazoleEsomeprazole 20 mg,clarithromycin 500 mg, amoxicillin 1000 mg, and colloidal bismuth pectin 200 mg twice daily for 14 days. |
| minocycline-based bismuth quadruple regimen for 10 days | Experimental | Drug: Minocycline hydrochloride capsule, Drug: Amoxicillin, Drug: colloidal bismuth pectin, Drug: esomeprazoleEsomeprazole 20 mg, minocycline 100 mg, amoxicillin 1000 mg, and colloidal bismuth pectin 200 mg twice daily for 10 days. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- H.pylori-positive outpatients with endoscopically proven chronic gastritis
- H. pylori (+) determined by either the 14C-or 13C-urea breath test or the gastric mucosal tissue rapid urease test and pathological section staining
- Treatment-naive patients for eradication of H.pylori infection
- Fully informed and agreed to participate in this study
Key exclusion criteria (8 listed)
- Age <18 years or >70 years
- Allergy to any of the study drugs
- Use of any drug that could influence the study results 4 weeks before the study,such as antibiotics,bismuth agent,PPI or H2 receptor antagonist (H2RA)
- Previous gastric or esophageal surgery
- Patients with malignancy or severe comorbidity
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 |
|---|---|---|
| Minocycline hydrochloride capsuleAlso: MeimanAntibiotic for H. pylori eradication | Drug | minocycline-based bismuth quadruple regimen for 10 days, minocycline-based bismuth quadruple regimen for 14 days |
| ClarithromycinAlso: KlacidAntibiotic for H. pylori eradication | Drug | clarithromycin-based bismuth quadruple regimen for 14 days |
| AmoxicillinAntibiotic for H. pylori eradication | Drug | clarithromycin-based bismuth quadruple regimen for 14 days, minocycline-based bismuth quadruple regimen for 10 days, minocycline-based bismuth quadruple regimen for 14 days |
| colloidal bismuth pectinGastric mucosal protective drug with anti-H. pylori effect | Drug | clarithromycin-based bismuth quadruple regimen for 14 days, minocycline-based bismuth quadruple regimen for 10 days, minocycline-based bismuth quadruple regimen for 14 days |
| esomeprazoleProton pump inhibitor | Drug | clarithromycin-based bismuth quadruple regimen for 14 days, minocycline-based bismuth quadruple regimen for 10 days, minocycline-based bismuth quadruple regimen for 14 days |
Primary outcome
Eradication rate
Time frame: 4-12 weeks after treatment
Helicobacter pylori eradication of minocycline-containing bismuth quadruple therapy
1 secondary outcome
incidence of adverse effects
Time frame: 3-7 days after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2022.
- Individual participant dataSharing planned: No
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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.
Qin Du, master principal investigator
2nd Affiliated Hospital,School of Medicine,Zhejiang University,China
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Minocycline hydrochloride capsule, Clarithromycin and Amoxicillin in people with Helicobacter Pylori Eradication, run by Second Affiliated Hospital, Zhejiang University, School of Medicine.
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 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 13 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
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 Yan Li, master (15906698496, liyan_8786@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Eradication rate (time frame: 4-12 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 13 Jan 2022.