Efficacy and Safety of Dual Therapy for Helicobacter Pylori Eradication
NCT ID: NCT05469685
Last Updated: 2024-06-13
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.
COMPLETED
PHASE4
914 participants
INTERVENTIONAL
2022-08-01
2023-09-30
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.
Optimization of Vonoprazan-based Dual Therapy for Helicobacter Pylori
NCT05649540
Helicobacter Pylori and Vonoprazan Dual Therapy
NCT05649709
Zuojin Wan Combined with Vonoprazan-Amoxicillin Dual Therapy in H.Pylori Eradication
NCT06901375
The Effect of Probiotics on Gut Microbiotain After Helicobacter Pylori Eradication
NCT05658055
Dual Therapy With Vonoprazan Plus Amoxicillin or Doxycycline Versus Bismuth Quadruple Therapy for Helicobacter Pylori Eradication:A Prospective, Multicenter, Open-label Randomized Controlled Study.
NCT06412588
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Before receiving the treatment plan, general information and relevant medical history of the subjects were collected through electronic questionnaires.The experimental data will be collected and recorded through follow-up by phone or WeChat during the experiment.
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.
10-day treatment group
vonoprazan 20mg bid and amoxicillin 1000mg tid for 10 days
Vonoprazan
Potassium-competitive acid blocker
Amoxicillin
Antibiotic for H. pylori eradication
14-day treatment group
vonoprazan 20mg bid and amoxicillin 1000mg tid for 14 days
Vonoprazan
Potassium-competitive acid blocker
Amoxicillin
Antibiotic for H. pylori eradication
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Vonoprazan
Potassium-competitive acid blocker
Amoxicillin
Antibiotic for H. pylori eradication
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. patients who are diagnosed with Helicobacter pylori;
3. treatment-naive patients or patients who failed to eradicate Helicobacter pylori in the past but haven't undergone eradication therapy in the past six months;
4. voluntary to be involved in the study and written informed consent was obtained from all patients
Exclusion Criteria
2. patients with peptic ulcer;
3. patients who underwent eradication therapy for Helicobacter pylori during the last six months;
4. patients who took antibiotics,bismuth agents,probiotics within four weeks prior to treatment and those who took H2 receptor antagonists,proton pump inhibitors(PPIs) or potassium competitive acid blockers within two weeks prior to treatment;
5. patients who are taking glucocorticoids, non-steroidal anti-inflammatory drugs or anticoagulants;
6. patients who have history of esophageal or gastric surgery;
7. pregnant or lactating women;
8. patients who have severe concurrent diseases such as hepatic,cardiovascular,respiratory,renal disorders or malignancies;
9. Alcohol abusers
18 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Nanjing First Hospital, Nanjing Medical University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Zhenyu Zhang
Director of Gastroenterology
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Zhenyu Zhang
Role: STUDY_CHAIR
Nanjing First Hospital, Nanjing Medical University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Affiliated Hospital of Integrated Traditional Chinese and Western Medicine, Nanjing University of Chinese Medicine
Nanjing, Jiangsu, China
Nanjing First Hospital, Nanjing Medical University
Nanjing, Jiangsu, China
Changshu No.1 People's Hospital
Suzhou, Jiangsu, China
Second Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
Taixing People's Hospital
Taizhou, Jiangsu, China
Taizhou Fourth People's Hospital
Taizhou, Jiangsu, China
Wuxi People's Hospital Affiliated to Nanjing Medical University
Wuxi, Jiangsu, China
The First People's Hospital of Xuzhou, Xuzhou Municipal Hospital Affiliated to Xuzhou Medical University
Xuzhou, Jiangsu, China
Yancheng First Hospital,Affiliated Hospital of Nanjing University Medical School
Yancheng, Jiangsu, China
Affiliated Hospital of Yangzhou University
Yangzhou, Jiangsu, China
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Sugano K, Tack J, Kuipers EJ, Graham DY, El-Omar EM, Miura S, Haruma K, Asaka M, Uemura N, Malfertheiner P; faculty members of Kyoto Global Consensus Conference. Kyoto global consensus report on Helicobacter pylori gastritis. Gut. 2015 Sep;64(9):1353-67. doi: 10.1136/gutjnl-2015-309252. Epub 2015 Jul 17.
Ford AC, Malfertheiner P, Giguere M, Santana J, Khan M, Moayyedi P. Adverse events with bismuth salts for Helicobacter pylori eradication: systematic review and meta-analysis. World J Gastroenterol. 2008 Dec 28;14(48):7361-70. doi: 10.3748/wjg.14.7361.
Rimbara E, Noguchi N, Kawai T, Sasatsu M. Mutations in penicillin-binding proteins 1, 2 and 3 are responsible for amoxicillin resistance in Helicobacter pylori. J Antimicrob Chemother. 2008 May;61(5):995-8. doi: 10.1093/jac/dkn051. Epub 2008 Feb 14.
Furuta T, Graham DY. Pharmacologic aspects of eradication therapy for Helicobacter pylori Infection. Gastroenterol Clin North Am. 2010 Sep;39(3):465-80. doi: 10.1016/j.gtc.2010.08.007.
Gao CP, Zhang D, Zhang T, Wang JX, Han SX, Graham DY, Lu H. PPI-amoxicillin dual therapy for Helicobacter pylori infection: An update based on a systematic review and meta-analysis. Helicobacter. 2020 Aug;25(4):e12692. doi: 10.1111/hel.12692. Epub 2020 Apr 20.
Berry V, Jennings K, Woodnutt G. Bactericidal and morphological effects of amoxicillin on Helicobacter pylori. Antimicrob Agents Chemother. 1995 Aug;39(8):1859-61. doi: 10.1128/AAC.39.8.1859.
Dong Y, Duan Z, Liu M, Ding Y, Chen G, Wang R, Xu X, Ding L, Zhan Q, Pan C, Li H, Yang F, Dai X, Li X, Wu X, Peng P, Wang J, Hu K, Hu D, Jie Q, Zhang Z. Efficacy and cost-effectiveness analysis of 10-day versus 14-day eradication of Helicobacter pylori infection with vonoprazan amoxicillin: a prospective, multicenter, randomized controlled trial. Front Pharmacol. 2025 Mar 24;16:1543352. doi: 10.3389/fphar.2025.1543352. eCollection 2025.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
KY20220701-06
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.