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

NCT07121205 | Completed

• 1 other identifier: KYLL-2025-07-009
• Study Type: observational
• Target: 1,600
• Locations: 1 country
• Sites: 1

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.

Conditions

HELICOBACTER PYLORI INFECTIONS

Keywords

Helicobacter pylori; dual therapy

Outcome Measures

Primary Outcomes (2)

• Eradication rate

  Comparison of Eradication Rates among Four Different High-Dose Dual Therapies for Helicobacter pylori

  4-6 weeks

• Comparison of Eradication Rates Among Four Different High-Dose Dual Therapies for Helicobacter pylori

  4-6 weeks

Secondary Outcomes (1)

• Adverse Events and Compliance

  4-6 weeks

Study Arms (4)

VA-10 day group

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

VA-14 day group

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

TA group

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

EA group

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. OTHER

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

EA group; TA group; VA-10 day group; VA-14 day group

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

(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.

You may qualify if:

• (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.

You may not qualify if:

• (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.

Sponsors & Collaborators

• Liyueyue: lead
• Qilu Hospital of Shandong University: collaborator

Study Sites (1)

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

Jinan, Shandong, Wenhuaxilu, China

Location

Related Publications (2)

• 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.

  PMID: 39924057 BACKGROUND

• 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.

  PMID: 40624406 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

De-identified clinical data from medical records (e.g., treatment history, adverse events) were stored in encrypted Excel files. No biological samples retained.

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: August 4, 2025
• First Posted: August 13, 2025
• Study Start: June 1, 2025
• Primary Completion: July 1, 2025
• Study Completion: July 20, 2025
• Last Updated: August 13, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)