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

NCT06723197 | Recruiting Phase 4

• 1 other identifier: 202411
• Study Type: interventional
• Target: 330
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

HELICOBACTER PYLORI INFECTIONS

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Rate of adverse reactions

  Immediately after treatment

• Patient compliance

  Immediately after treatment

Study Arms (3)

14-day dual regimen

ACTIVE COMPARATOR

Drug: vonoprazan+amoxicillin; Other: Duration of eradication regimen: 14-day

10-day dual regimen

EXPERIMENTAL

Drug: vonoprazan+amoxicillin; Other: Duration of eradication regimen: 10-day

7-day quadruple regimen

EXPERIMENTAL

Other: Duration of eradication regimen: 7-day; Drug: vonoprazan+amoxicillin+tetracycline+bismuth

Interventions

vonoprazan+amoxicillin DRUG

Drug combinations for dual regimens：vonoprazan+amoxicillin

10-day dual regimen; 14-day dual regimen

Duration of eradication regimen: 7-day OTHER

Duration of eradication regimen: 7-day

7-day quadruple regimen

vonoprazan+amoxicillin+tetracycline+bismuth DRUG

Drug combinations for quadruple regimens: vonoprazan+amoxicillin+tetracycline+bismuth

7-day quadruple regimen

Duration of eradication regimen: 10-day OTHER

Duration of eradication regimen: 10-day

10-day dual regimen

Duration of eradication regimen: 14-day OTHER

Duration of eradication regimen: 14-day

14-day dual regimen

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shandong University: lead
• Zibo Maternal and Child Health Hospital: collaborator
• Zaozhuang Municipal Hospital: collaborator
• Feicheng Municipal People's Hospital: collaborator
• Shandong University of Traditional Chinese Medicine: collaborator
• The People's Hospital of Jimo.Qingdao: collaborator
• Dezhou Hospital Qilu Hospital of Shandong University: collaborator

Study Sites (1)

Qilu Hospital of Shandong University

Jinan, Shandong, 250012, China

RECRUITING

Related Publications (5)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

Central Study Contacts

Yanqing Li, Ph.D

CONTACT

+8653188369277; liyanqing@sdu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ph.D

Study Record Dates

• First Submitted: November 27, 2024
• First Posted: December 9, 2024
• Study Start: December 10, 2024
• Primary Completion: October 1, 2025
• Study Completion: November 30, 2025
• Last Updated: December 11, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)