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Completed

NCT Number: NCT07333001

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

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.

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Key information

Conditions

HELICOBACTER PYLORI INFECTIONS

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Qilu Hospital of Shandong University

Jinan, Shandong, 250012, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

7-day triple therapy

Drug

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

14-day dual therapy

Drug

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

Primary outcomes

  1. eradication rate

    Time frame: six weeks after treatment

Secondary outcomes

  1. incidence of adverse events

    Time frame: immediately after treatment

Sponsors and collaborators

Lead sponsor

Yueyue Li

Other

Collaborators

  • Qilu Hospital of Shandong University

Registry information

Acronym: PSM

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jan 12, 2026
Registry last updated
Jan 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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