Helicobacter Pylori Eradication and Follow-up
1 other identifier
interventional
4,447
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Sep 2021
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 12, 2021
CompletedFirst Posted
Study publicly available on registry
September 30, 2021
CompletedStudy Start
First participant enrolled
September 30, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2026
September 30, 2021
September 1, 2021
4.8 years
September 12, 2021
September 29, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Eradication rate of Helicobacter pylori
Eradication of Helicobacter pylori was defined as negative result of urea breath test (\<4‰ cut-off value).
6 weeks
Secondary Outcomes (2)
Eradication rate of Helicobacter pylori resistant strains
6 weeks
Eradication rate of Helicobacter pylori susceptible strains
6 weeks
Other Outcomes (2)
Adherence rate
2 weeks during therapy
Frequency of adverse events
2 weeks during therapy
Study Arms (10)
RBCL
EXPERIMENTALRabeprazole 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
EXPERIMENTALRabeprazole 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
EXPERIMENTALRabeprazole 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
EXPERIMENTALRabeprazole 20 mg bid, and Amoxicillin 1.0 g tid for 14 days
RAB
EXPERIMENTALRabeprazole 20 mg bid, bismuth potassium citrate 0.6 g bid, and Amoxicillin 1.0 g tid for 14 days
RAM
EXPERIMENTALRabeprazole 20 mg bid, metronidazole 0.4 g tid, and Amoxicillin 1.0 g tid for 14 days
RBAM
EXPERIMENTALRabeprazole 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
EXPERIMENTALRabeprazole 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
EXPERIMENTALRabeprazole 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 COMPARATORRabeprazole 20 mg bid, bismuth potassium citrate 0.6 g bid, metronidazole 0.4 g qid, and tetracycline 0.5 g qid for 14 days
Interventions
Eligibility Criteria
You may qualify if:
- Participate in the trial voluntarily, fully understand the trial, and sign the informed consent form (ICF).
- years old on the day of signing the ICF.
- Helicobacter pylori infection confirmed by 13C-urea breath test or rapid urease test.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200032, China
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Taotao Liu, MD
Fudan University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 12, 2021
First Posted
September 30, 2021
Study Start
September 30, 2021
Primary Completion (Estimated)
June 30, 2026
Study Completion (Estimated)
June 30, 2026
Last Updated
September 30, 2021
Record last verified: 2021-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- Beginning 6 months and ending 5 years after the trial results were published.
- 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.
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.