Efficacy of Different Durations of Dual and Quadruple Regimens for Helicobacter Pylori Eradication
NCT ID: NCT06723197
Last Updated: 2024-12-11
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
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RECRUITING
PHASE4
330 participants
INTERVENTIONAL
2024-12-10
2025-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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14-day dual regimen
vonoprazan+amoxicillin
Drug combinations for dual regimens：vonoprazan+amoxicillin
Duration of eradication regimen: 14-day
Duration of eradication regimen: 14-day
10-day dual regimen
vonoprazan+amoxicillin
Drug combinations for dual regimens：vonoprazan+amoxicillin
Duration of eradication regimen: 10-day
Duration of eradication regimen: 10-day
7-day quadruple regimen
Duration of eradication regimen: 7-day
Duration of eradication regimen: 7-day
vonoprazan+amoxicillin+tetracycline+bismuth
Drug combinations for quadruple regimens: vonoprazan+amoxicillin+tetracycline+bismuth
Interventions
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vonoprazan+amoxicillin
Drug combinations for dual regimens：vonoprazan+amoxicillin
Duration of eradication regimen: 7-day
Duration of eradication regimen: 7-day
vonoprazan+amoxicillin+tetracycline+bismuth
Drug combinations for quadruple regimens: vonoprazan+amoxicillin+tetracycline+bismuth
Duration of eradication regimen: 10-day
Duration of eradication regimen: 10-day
Duration of eradication regimen: 14-day
Duration of eradication regimen: 14-day
Eligibility Criteria
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Inclusion Criteria
2. Patients with H.pylori infection (13C/14C-urea breath test)
3. Patients without previous treatment for H. pylori eradication
Exclusion Criteria
2. Patients with active gastrointestinal bleeding
3. Patients with a history of upper gastrointestinal surgery
4. Patients allergic to treatment drugs
5. Patients with medication history of bismuth, antibiotics within 4 weeks, or proton pump inhibitor within 2 weeks
6. Patients who are pregnant or lactating or unwilling to take contraceptive measures during the trial
7. Patients with other behaviors that may increase the risk of illness, such as alcohol and drug abuse
8. Patients who are unwilling or incapable to provide informed consents
18 Years
70 Years
ALL
No
Sponsors
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Zibo Maternal and Child Health Hospital
UNKNOWN
Zaozhuang Municipal Hospital
OTHER
Feicheng Municipal People's Hospital
UNKNOWN
Shandong University of Traditional Chinese Medicine
OTHER
The People's Hospital of Jimo.Qingdao
UNKNOWN
Dezhou Hospital Qilu Hospital of Shandong University
OTHER
Shandong University
OTHER
Responsible Party
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Yanqing Li
Ph.D
Locations
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Qilu Hospital of Shandong University
Jinan, Shandong, China
Countries
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Central Contacts
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Facility Contacts
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Yueyue Li
Role: primary
References
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Qian HS, Li WJ, Dang YN, Li LR, Xu XB, Yuan L, Zhang WF, Yang Z, Gao X, Zhang M, Li X, Zhang GX. Ten-Day Vonoprazan-Amoxicillin Dual Therapy as a First-Line Treatment of Helicobacter pylori Infection Compared With Bismuth-Containing Quadruple Therapy. Am J Gastroenterol. 2023 Apr 1;118(4):627-634. doi: 10.14309/ajg.0000000000002086. Epub 2022 Dec 2.
Du RC, Hu YX, Ouyang Y, Ling LX, Xu JY, Sa R, Liu XS, Hong JB, Zhu Y, Lu NH, Hu Y. Vonoprazan and amoxicillin dual therapy as the first-line treatment of Helicobacter pylori infection: A systematic review and meta-analysis. Helicobacter. 2024 Jan-Feb;29(1):e13039. doi: 10.1111/hel.13039. Epub 2023 Nov 30.
Zhou L, Lu H, Song Z, Lyu B, Chen Y, Wang J, Xia J, Zhao Z; on behalf of Helicobacter Pylori Study Group of Chinese Society of Gastroenterology. 2022 Chinese national clinical practice guideline on Helicobacter pylori eradication treatment. Chin Med J (Engl). 2022 Dec 20;135(24):2899-2910. doi: 10.1097/CM9.0000000000002546.
Crowe SE. Helicobacter pylori Infection. N Engl J Med. 2019 Mar 21;380(12):1158-1165. doi: 10.1056/NEJMcp1710945. No abstract available.
Li Y, Choi H, Leung K, Jiang F, Graham DY, Leung WK. Global prevalence of Helicobacter pylori infection between 1980 and 2022: a systematic review and meta-analysis. Lancet Gastroenterol Hepatol. 2023 Jun;8(6):553-564. doi: 10.1016/S2468-1253(23)00070-5. Epub 2023 Apr 20.
Other Identifiers
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202411
Identifier Type: -
Identifier Source: org_study_id