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Recruiting NCT06723197

Efficacy of Different Durations of Dual and Quadruple Regimens for Helicobacter Pylori Eradication

Phase IV Interventional HELICOBACTER PYLORI INFECTIONS

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: vonoprazan+amoxicillin, Duration of eradication regimen: 7-day, vonoprazan+amoxicillin+tetracycline+bismuth, Duration of eradication regimen: 10-day.
Who it may be relevant to
Registry conditions: HELICOBACTER PYLORI INFECTIONS. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Efficacy of Different Durations of Dual and Quadruple Regimens for Helicobacter Pylori Eradication: a Multicentre, Randomised, Controlled Trial

Overview

The study aimed to compare the efficacy and safety of dual and quadruple regimens with different durations (7-day, 10-day, 14-day) for the eradication of Helicobacter pylori. Subjects were randomized to receive the intervention and were reviewed by 13C-urea breath test after 6 weeks. The eradication rates, adverse reaction rates and patient adherence were calculated.

Interventions

  • Drug vonoprazan+amoxicillin
    Drug combinations for dual regimens：vonoprazan+amoxicillin
  • Other Duration of eradication regimen: 7-day
    Duration of eradication regimen: 7-day
  • Drug vonoprazan+amoxicillin+tetracycline+bismuth
    Drug combinations for quadruple regimens: vonoprazan+amoxicillin+tetracycline+bismuth
  • Other Duration of eradication regimen: 10-day
    Duration of eradication regimen: 10-day
  • Other Duration of eradication regimen: 14-day
    Duration of eradication regimen: 14-day

Primary outcome measures

  • Eradication rate [Time frame: Six weeks after treatment]
Secondary outcome measures (2)
  • Rate of adverse reactions [Time frame: Immediately after treatment]
  • Patient compliance [Time frame: Immediately after treatment]

Eligibility criteria

Inclusion criteria

  • Patients aged 18-70 years old
  • Patients with H.pylori infection (13C/14C-urea breath test)
  • Patients without previous treatment for H. pylori eradication

Exclusion criteria

  • Patients with serious underlying diseases, such as liver insufficiency (Aspartate aminotransferase or alanine aminotransferase greater than the normal value), renal insufficiency (Cr≥2.0mg/dL or glomerular filtration rate <50 ml/min), immunosuppression, malignant tumors, Coronary heart disease or coronary artery stenosis ≥75%
  • Patients with active gastrointestinal bleeding
  • Patients with a history of upper gastrointestinal surgery
  • Patients allergic to treatment drugs
  • Patients with medication history of bismuth, antibiotics within 4 weeks, or proton pump inhibitor within 2 weeks
  • Patients who are pregnant or lactating or unwilling to take contraceptive measures during the trial
  • Patients with other behaviors that may increase the risk of illness, such as alcohol and drug abuse
  • Patients who are unwilling or incapable to provide informed consents

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Qilu Hospital of Shandong University — Jinan

Publications

  • 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. PMID 36729890
  • 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. PMID 38036941
  • 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. PMID 36579940
  • Crowe SE. Helicobacter pylori Infection. N Engl J Med. 2019 Mar 21;380(12):1158-1165. doi: 10.1056/NEJMcp1710945. No abstract available. PMID 30893536
  • 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. PMID 37086739
  • Ju K, Zhao H, Guo L, Zhai Z, Song X, Zhao H, Zhang W, Li X, Zhang H, Xia W, Zheng R, Liu S, Sun L, Ding R, Liu X, Teng T, Kong Q, Li Y, Zuo X, Li Y. Vonoprazan-Based Dual and Quadruple Therapy with Varying Duration for Helicobacter pylori Eradication: A Multicenter, Randomized Controlled Trial. Int J Antimicrob Agents. 2026 Jul 31:107948. doi: 10.1016/j.ijantimicag.2026.107948. Online ahead of pri PMID 42537821

Identifiers

NCT: NCT06723197 · 202411

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗