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

NCT07333001 | Completed

• 1 other identifier: 202512
• Study Type: observational
• Target: 508
• Locations: 1 country
• Sites: 1

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

Keywords

Helicobacter pylori; triple therapy; dual therapy

Outcome Measures

Primary Outcomes (1)

• eradication rate

  six weeks after treatment

Secondary Outcomes (1)

• incidence of adverse events

  immediately after treatment

Study Arms (2)

triple therapy

Drug: 7-day triple therapy

dual therapy

Drug: 14-day dual therapy

Interventions

14-day dual therapy DRUG

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

dual therapy

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

triple therapy

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yueyue Li: lead
• Qilu Hospital of Shandong University: collaborator

Study Sites (1)

Qilu Hospital of Shandong University

Jinan, Shandong, 250012, China

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 27, 2025
• First Posted: January 12, 2026
• Study Start: November 1, 2025
• Primary Completion: December 15, 2025
• Study Completion: December 27, 2025
• Last Updated: January 12, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)