Efficacy and Safety of 7-day Triple Therapy Containing Amoxicillin and Tetracycline Versus 14-day Dual Therapy for Helicobacter Pylori Eradication

NCT ID: NCT07333001

Last Updated: 2026-01-12

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 508 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-11-01
• Study Completion Date: 2025-12-27

Brief Summary

With the increasing prevalence of antibiotic resistance, the clinical efficacy of conventional 7-day triple therapy for Helicobacter pylori eradication has been substantially diminished. However, the efficacy and safety of a 7-day triple regimen based on amoxicillin and tetracycline warrant further investigation. This retrospective study was designed to compare the efficacy and safety of a 7-day triple therapy based on amoxicillin and tetracycline combination versus the standard 14-day high-dose dual therapy for H. pylori infection. Data on therapies for H. pylori eradication were extracted between January 2023 and October 2025 at Qilu Hospital of Shandong University. Two regimens were compared based on 1:3 propensity score matching: 7-day triple therapy (vonoprazan 20 mg twice daily, amoxicillin 1000 mg twice daily, and tetracycline 500 mg four times daily) and 14-day high-dose dual therapy (vonoprazan 20 mg twice daily and amoxicillin 1000 mg three times daily). Eradication rates and incidence of adverse events were assessed.

Conditions

HELICOBACTER PYLORI INFECTIONS

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

triple therapy

7-day triple therapy

Intervention Type: DRUG

vonoprazan 20 mg twice daily, amoxicillin 1000 mg twice daily, and tetracycline 500 mg four times daily for 7 days

dual therapy

14-day dual therapy

Intervention Type: DRUG

vonoprazan 20 mg twice daily and amoxicillin 1000 mg three times daily for 14 days

Interventions

7-day triple therapy

vonoprazan 20 mg twice daily, amoxicillin 1000 mg twice daily, and tetracycline 500 mg four times daily for 7 days

Intervention Type: DRUG

14-day dual therapy

vonoprazan 20 mg twice daily and amoxicillin 1000 mg three times daily for 14 days

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• patients aged 18-70 years;
• patients with H. pylori infection confirmed by 13C/14C-urea breath test or rapid urease test;
• patients with no history of H. pylori eradication therapy

Exclusion Criteria

• patients with severe underlying diseases, such as hepatic insufficiency, renal insufficiency, immunosuppression, malignant tumors, and coronary heart disease;
• 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 inhibitors within 2 weeks;
• patients who were pregnant or lactating or unwilling to take contraceptive measures during the trial;
• patients with other behaviors that may increase the risk of disease, such as alcohol and drug abuse;
• incomplete data.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Qilu Hospital of Shandong University

OTHER

Sponsor Role: collaborator

Yueyue Li

OTHER

Sponsor Role: lead

Responsible Party

Yueyue Li

Associate Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Qilu Hospital of Shandong University

Jinan, Shandong, China

Countries

China

Other Identifiers

202512

Identifier Type: -

Identifier Source: org_study_id