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

December 30, 2025 updated by: Yueyue Li
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

508

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shandong
      • Jinan, Shandong, China, 250012
        • Qilu Hospital of Shandong University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

  • 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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
triple therapy
Drug: 7-day triple therapy
vonoprazan 20 mg twice daily, amoxicillin 1000 mg twice daily, and tetracycline 500 mg four times daily for 7 days
dual therapy
Drug: 14-day dual therapy
vonoprazan 20 mg twice daily and amoxicillin 1000 mg three times daily for 14 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
eradication rate
Time Frame: six weeks after treatment
six weeks after treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
incidence of adverse events
Time Frame: immediately after treatment
immediately after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yueyue Li

Collaborators

Qilu Hospital of Shandong University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2025

Primary Completion (Actual)

December 15, 2025

Study Completion (Actual)

December 27, 2025

Study Registration Dates

First Submitted

December 27, 2025

First Submitted That Met QC Criteria

December 30, 2025

First Posted (Estimated)

January 12, 2026

Study Record Updates

Last Update Posted (Estimated)

January 12, 2026

Last Update Submitted That Met QC Criteria

December 30, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 202512

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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