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

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

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.

Study Overview

• Status: Recruiting
• Conditions: HELICOBACTER PYLORI INFECTIONS
• Intervention / Treatment: Drug: vonoprazan+amoxicillin; Other: Duration of eradication regimen: 14-day; Other: Duration of eradication regimen: 10-day; Other: Duration of eradication regimen: 7-day; Drug: vonoprazan+amoxicillin+tetracycline+bismuth

• Study Type: Interventional
• Enrollment (Estimated): 330
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Yanqing Li, Ph.D; Phone Number: +8653188369277; Email: liyanqing@sdu.edu.cn

Study Locations

• China
  • Shandong
    • Jinan, Shandong, China, 250012
      • Recruiting
      • Qilu Hospital of Shandong University
      • Contact: Yueyue Li; Phone Number: +86-18560089751; Email: lyynqj@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. 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%
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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 14-day dual regimen	Drug: vonoprazan+amoxicillin; Drug combinations for dual regimens：vonoprazan+amoxicillin; Other: Duration of eradication regimen: 14-day; Duration of eradication regimen: 14-day
Experimental: 10-day dual regimen	Drug: vonoprazan+amoxicillin; Drug combinations for dual regimens：vonoprazan+amoxicillin; Other: Duration of eradication regimen: 10-day; Duration of eradication regimen: 10-day
Experimental: 7-day quadruple regimen	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Eradication rate	13C-urea breath test was used to determine whether eradication was successful. Both intention to treat (ITT) and per-protocol (PP) analyses will be used for the assessment of the eradication rates of Helicobacter pylori infections in the three groups. The ITT analysis includes all randomly assigned patients who take at least one dose of the study medications. The PP analysis is limited to patients who take over 90% of the study medications and complete follow-up.	Six weeks after treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of adverse reactions	Drug-related adverse reactions needs to be recorded after treatment	Immediately after treatment
Patient compliance	The number of missed and overdosed doses of medication needs to be completed after treatment.	Immediately after treatment

Collaborators and Investigators

• Sponsor: Shandong University
• Collaborators: The Second Affiliated Hospital of Shandong University of traditional Chinese Medicine; Zaozhuang Municipal Hospital; The People's Hospital of Jimo.Qingdao; Zibo Maternal and Child Health Hospital; Qilu hospital of Shandong University Dezhou hospital; Feicheng Municipal People's Hospital

Publications and helpful links

General Publications

• 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.
• 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; 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. Erratum In: Chin Med J (Engl). 2024 May 5;137(9):1068. doi: 10.1097/CM9.0000000000003134.

Study record dates

Study Major Dates

• Study Start (Actual): December 10, 2024
• Primary Completion (Estimated): October 1, 2025
• Study Completion (Estimated): November 30, 2025

Study Registration Dates

• First Submitted: November 27, 2024
• First Submitted That Met QC Criteria: December 4, 2024
• First Posted (Actual): December 9, 2024

Study Record Updates

• Last Update Posted (Estimated): December 11, 2024
• Last Update Submitted That Met QC Criteria: December 10, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Anti-Bacterial Agents; Anti-Infective Agents; Molecular Mechanisms of Pharmacological Action; Gastrointestinal Agents; Enzyme Inhibitors; Antacids; Protein Synthesis Inhibitors; Tetracycline; Bismuth; Amoxicillin
• Other Study ID Numbers: 202411

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No