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

NCT ID: NCT07121205

Last Updated: 2025-08-13

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1600 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-06-01
• Study Completion Date: 2025-07-20

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.

Conditions

HELICOBACTER PYLORI INFECTIONS

Study Design

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

Study Groups

VA-10 day group

This study is a retrospective study, and all data have been collected in advance with no active intervention required.

Intervention Type: OTHER

This study is a retrospective study, and all data have been collected in advance with no active intervention required.

VA-14 day group

This study is a retrospective study, and all data have been collected in advance with no active intervention required.

Intervention Type: OTHER

This study is a retrospective study, and all data have been collected in advance with no active intervention required.

TA group

This study is a retrospective study, and all data have been collected in advance with no active intervention required.

Intervention Type: OTHER

This study is a retrospective study, and all data have been collected in advance with no active intervention required.

EA group

This study is a retrospective study, and all data have been collected in advance with no active intervention required.

Intervention Type: OTHER

This study is a retrospective study, and all data have been collected in advance with no active intervention required.

Interventions

This study is a retrospective study, and all data have been collected in advance with no active intervention required.

This study is a retrospective study, and all data have been collected in advance with no active intervention required.

Intervention Type: OTHER

Eligibility Criteria

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.

• 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

Liyueyue

OTHER

Sponsor Role: lead

Responsible Party

Liyueyue

Associate Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Department of Gastroenterology, Qilu Hospital of Shandong University, Jinan, Shandong, China.

Jinan, Shandong, China

Countries

China

References

Wiklund AK, Santoni G, Yan J, Radkiewicz C, Xie S, Birgisson H, Ness-Jensen E, von Euler-Chelpin M, Kauppila JH, Lagergren J. Risk of Gastric Adenocarcinoma After Eradication of Helicobacter pylori. Gastroenterology. 2025 Aug;169(2):244-250.e1. doi: 10.1053/j.gastro.2025.01.239. Epub 2025 Feb 7.

Reference Type: BACKGROUND

PMID: 39924057 (View on PubMed)

Park JY, Georges D, Alberts CJ, Bray F, Clifford G, Baussano I. Global lifetime estimates of expected and preventable gastric cancers across 185 countries. Nat Med. 2025 Sep;31(9):3020-3027. doi: 10.1038/s41591-025-03793-6. Epub 2025 Jul 7.

Reference Type: BACKGROUND

PMID: 40624406 (View on PubMed)

Other Identifiers

KYLL-2025-07-009

Identifier Type: OTHER

Identifier Source: secondary_id

KYLL-2025-07-009

Identifier Type: -

Identifier Source: org_study_id