HELICOBACTER PYLORI INFECTIONS
Conditions
Keywords
Helicobacter pylori, dual therapy
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.
Interventions
This study is a retrospective study, and all data have been collected in advance with no active intervention required.
Sponsors
Qilu Hospital of Shandong University
Liyueyue
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame |
|---|---|
| Adverse Events and Compliance | 4-6 weeks |
Countries
China
Outcome results
None listed