High-Dose Dual Therapy for H. Pylori Eradication (RETRO-HP Study)

Completed

• Conditions: HELICOBACTER PYLORI INFECTIONS

• Registration Number: NCT07121205
• Lead Sponsor: Liyueyue

Brief Summary

Background:

High-dose dual therapy (HDDT) has emerged as a potential first-line treatment for Helicobacter pylori infection, but its efficacy and safety across different regimens and populations remain unclear. This study aimed to compare real-world outcomes of various HDDT protocols and identify factors influencing treatment failure.

Methods:

A multicenter retrospective analysis was conducted using data from 15 medical centers (January 2022-January 2025). Patients received one of four HDDT regimens: vonoprazan-amoxicillin for 10 days (VA-10) or 14 days (VA-14), esomeprazole-amoxicillin (EA), or tegoprazan-amoxicillin (TA). Primary outcomes included eradication rates (modified intention-to-treat analysis) and adverse events.

Detailed Description

This study is a multicenter, retrospective, observational study utilizing medical records of outpatients who received standard high-dose dual therapy (HDDT) for Helicobacter pylori eradication between January 2022 and January 2025. The aim was to compare the efficacy and adverse event rates of different HDDT regimens.

Collected data included:

Baseline demographics (age, sex, etc.)

Medical/lifestyle history

Treatment regimens

Adverse events

Compliance

All data were anonymized at collection, and no additional patient contact or information collection was required. Since this study involved only retrospective chart review without new interventions, patient consent was waived by the ethics committee.

Treatment Groups

Patients were categorized based on their actual prescribed regimens:

Amoxicillin + Vonoprazan (10-day course)

Amoxicillin + Vonoprazan (14-day course)

Amoxicillin + Tegoprazan (14-day course)

Amoxicillin + Esomeprazole (14-day course)

These groups were compared to assess differences in H. pylori eradication rates.

Study Characteristics No active intervention or real-time questionnaire collection was involved.

Complies with the real-world evidence (RWE) framework for retrospective studies.

Primary Outcome Eradication rate comparison between HDDT regimens (assessed via modified intention-to-treat analysis).

Secondary Outcomes Adverse event rates across different HDDT regimens.

Study Timeline

• Study Start: 2025-06-01
• Primary Completion: 2025-07-01
• Study Completion: 2025-07-20
• Status Verified: 2025-08
• Study First Submitted: 2025-08-04
• Study First Submitted QC: 2025-08-06
• Last Update Submitted: 2025-08-06
• Study First Posted: 2025-08-13
• Last Update Posted: 2025-08-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1600

Inclusion Criteria

• (1) patients aged 18-70 years, regardless of gender; (2) absent history of receiving H. pylori eradication therapy; (3) diagnosed with H. pylori infection through at least one of the following methods: rapid urease test, ¹³C/¹⁴C-urea breath test, or histopathological examination.

Exclusion Criteria

• (1) patients with incomplete medical records, including missing treatment details, absence of post-treatment follow-up test results, or failure to complete essential follow-up assessments; (2) patients who received treatment regimens that did not conform to the standardized HDDT protocol specified in this study.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Eradication rate	4-6 weeks	Comparison of Eradication Rates among Four Different High-Dose Dual Therapies for Helicobacter pylori
Comparison of Eradication Rates Among Four Different High-Dose Dual Therapies for Helicobacter pylori	4-6 weeks

Secondary Outcome Measures

Name	Time	Method
Adverse Events and Compliance	4-6 weeks

Trial Locations

Locations (1)

Department of Gastroenterology, Qilu Hospital of Shandong University, Jinan, Shandong, China.; 🇨🇳 Jinan, Shandong, China