- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05061732
Helicobacter Pylori Eradication and Follow-up
September 29, 2021 updated by: Shanghai Zhongshan Hospital
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.
Study Overview
Status
Recruiting
Conditions
Study Type
Interventional
Enrollment (Anticipated)
4447
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Shanghai
-
Shanghai, Shanghai, China, 200032
- Recruiting
- Zhongshan Hospital, Fudan University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: RBCL
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
|
0.5g bid
20mg bid
0.6g bid
0.5g qd
|
Experimental: RBLM
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
|
20mg bid
0.6g bid
0.4g qid
0.5g qd
0.4g tid
|
Experimental: RBCM
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
|
0.5g bid
20mg bid
0.6g bid
0.4g qid
0.4g tid
|
Experimental: RA
Rabeprazole 20 mg bid, and Amoxicillin 1.0 g tid for 14 days
|
20mg bid
1g tid
|
Experimental: RAB
Rabeprazole 20 mg bid, bismuth potassium citrate 0.6 g bid, and Amoxicillin 1.0 g tid for 14 days
|
20mg bid
0.6g bid
1g tid
|
Experimental: RAM
Rabeprazole 20 mg bid, metronidazole 0.4 g tid, and Amoxicillin 1.0 g tid for 14 days
|
20mg bid
0.4g qid
0.4g tid
1g tid
|
Experimental: RBAM
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
|
20mg bid
0.6g bid
0.4g qid
0.4g tid
1g tid
|
Experimental: RBAM4
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
|
20mg bid
0.6g bid
0.4g qid
0.4g tid
1g tid
|
Experimental: RBDM
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
|
20mg bid
0.6g bid
0.4g qid
0.4g tid
0.1g bid
|
Active Comparator: RBTM
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
|
20mg bid
0.6g bid
0.4g qid
0.4g tid
0.5g qid
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Eradication rate of Helicobacter pylori resistant strains
Time Frame: 6 weeks
|
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.
|
6 weeks
|
Eradication rate of Helicobacter pylori susceptible strains
Time Frame: 6 weeks
|
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.
|
6 weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Frequency of adverse events
Time Frame: 2 weeks during therapy
|
Any possible adverse events during the 14-day treatment period were recorded.
|
2 weeks during therapy
|
Adherence rate
Time Frame: 2 weeks during therapy
|
The proportion of subjects with good adherence.
Good adherence was defined as that subjects took more than 80% of the total medication.
|
2 weeks during therapy
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 30, 2021
Primary Completion (Anticipated)
June 30, 2026
Study Completion (Anticipated)
June 30, 2026
Study Registration Dates
First Submitted
September 12, 2021
First Submitted That Met QC Criteria
September 29, 2021
First Posted (Actual)
September 30, 2021
Study Record Updates
Last Update Posted (Actual)
September 30, 2021
Last Update Submitted That Met QC Criteria
September 29, 2021
Last Verified
September 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Antineoplastic Agents
- Gastrointestinal Agents
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Natriuretic Agents
- Anti-Bacterial Agents
- Diuretics
- Cytochrome P-450 CYP3A Inhibitors
- Cytochrome P-450 Enzyme Inhibitors
- Protein Synthesis Inhibitors
- Respiratory System Agents
- Antiprotozoal Agents
- Antiparasitic Agents
- Anti-Ulcer Agents
- Proton Pump Inhibitors
- Antimalarials
- Cytochrome P-450 CYP1A2 Inhibitors
- Expectorants
- Antacids
- Anti-Infective Agents, Urinary
- Renal Agents
- Metronidazole
- Rabeprazole
- Doxycycline
- Amoxicillin
- Clarithromycin
- Levofloxacin
- Bismuth
- Tetracycline
- Potassium Citrate
Other Study ID Numbers
- B2021-376
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
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.
IPD Sharing Time Frame
Beginning 6 months and ending 5 years after the trial results were published.
IPD Sharing Access Criteria
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.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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