The Evaluation of Triple Therapy With Vonoprazan, Amoxicillin and Bismuth for Eradication of Helicobacter Pylori
NCT ID: NCT05189444
Last Updated: 2022-03-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
672 participants
INTERVENTIONAL
2022-03-25
2022-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Vonoprazan-containing Triple Therapy Versus Empiric Bismuth Quadruple Therapy for First-line Helicobacter Pylori Treatment: a Randomized Clinical Trial
NCT05726734
Efficacies of Bismuth-amoxicillin-vonoprazan Triple Therapy, Vonoprazan-amoxicillin Dual Therapy and Proton Pump Inhibitor-based Standard Triple Therapy for Hp Eradication
NCT06349486
Vonoprazan Fumarate in Combination With Amoxicillin for the First-line Eradication of Helicobacter Pylori -- a Multicenter, Randomized, Parallel Controlled Study
NCT05196945
A Study of Vonoprazan in Adults With Helicobacter Pylori
NCT04753437
Helicobacter Rescue Therapy With Vonorazon and Amoxicillin Dual Therapy Versus Bismuth-containing Quadruple Therapy
NCT06168084
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Vonoprazan group
Vonoprazan + Amoxicillin + Bismuth potassium citrate Drug: Vonoprazan 20mg bid Other Names: no Drug: Amoxicillin 0.75g tid Other Names: no Drug: Bismuth potassium citrate 0.22g bid Other Names: no
Vonoprazan
20mg bid
Amoxicillin
0.75g tid
Bismuth potassium citrate
0.22g bid
control group: quadruple therapy
Drug: Esomeprazole 20mg bid Other Names: no Drug: Amoxicillin 1.0g bid Other Names: no Drug: Clarithromycin 0.5g bid Other Names:no Drug: Bismuth potassium citrate 0.22g bid Other Names:no
Esomeprazole
20mg bid
Amoxicillin
1.0g bid
Clarithromycin
0.5g bid
Bismuth potassium citrate
0.22g bid
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Vonoprazan
20mg bid
Amoxicillin
0.75g tid
Esomeprazole
20mg bid
Amoxicillin
1.0g bid
Clarithromycin
0.5g bid
Bismuth potassium citrate
0.22g bid
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* age 18\~65
Exclusion Criteria
* previous gastric resection
* allergic to the drugs used in this study
* previous use of proton pump inhibitors, bismuth, H2 receptor antagonist or antibiotics, probiotics within 4 weeks of the study
* Patients who were pregnant or lactating
* Patients taking NSAIDs, alcoholic or with other serious disease (e.g. hepatopathy, heart disease, nephropathy#diabete mellitus, hypertension…) effect the evaluation of this study
* Can't express the complaint correctly
18 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Huazhong University of Science and Technology
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Bin Cheng
Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Bin Cheng, Doctor
Role: PRINCIPAL_INVESTIGATOR
Tongji Hospital
si xiong, Doctor
Role: STUDY_CHAIR
Tongji Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Tongji Hospital, Tongji Medical College, HUST
Wuhan, Hubei, China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
References
Explore related publications, articles, or registry entries linked to this study.
Gunaratne AW, Hamblin H, Clancy A, Magat AJMC, Dawson MVM, Tu J, Borody TJ. Combinations of antibiotics and vonoprazan for the treatment of Helicobacter pylori infections-Exploratory study. Helicobacter. 2021 Oct;26(5):e12830. doi: 10.1111/hel.12830. Epub 2021 Jul 10.
Rokkas T, Gisbert JP, Malfertheiner P, Niv Y, Gasbarrini A, Leja M, Megraud F, O'Morain C, Graham DY. Comparative Effectiveness of Multiple Different First-Line Treatment Regimens for Helicobacter pylori Infection: A Network Meta-analysis. Gastroenterology. 2021 Aug;161(2):495-507.e4. doi: 10.1053/j.gastro.2021.04.012. Epub 2021 Apr 8.
Kiyotoki S, Nishikawa J, Sakaida I. Efficacy of Vonoprazan for Helicobacter pylori Eradication. Intern Med. 2020 Jan 15;59(2):153-161. doi: 10.2169/internalmedicine.2521-18. Epub 2019 Jun 27.
Ang TL, Ang D. Helicobacter pylori Treatment Strategies in Singapore. Gut Liver. 2021 Jan 15;15(1):13-18. doi: 10.5009/gnl19308.
Kao CY, Sheu BS, Wu JJ. Helicobacter pylori infection: An overview of bacterial virulence factors and pathogenesis. Biomed J. 2016 Feb;39(1):14-23. doi: 10.1016/j.bj.2015.06.002. Epub 2016 Apr 1.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Vonoprazan-Hp-2021
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.