Bismuth-containing Quadruple Therapy for Helicobacter Pylori Eradication

NCT07167511 | Completed

• 1 other identifier: 202508
• Study Type: observational
• Target: 1,730
• Locations: 1 country
• Sites: 1

Brief Summary

Bismuth-containing quadruple therapy was recommended as a first-line treatment for Helicobacter pylori infection. This study aimed to compare real-world outcomes of various bismuth-containging quadruple regimens and identify factors influencing treatment failure. A multicenter retrospective analysis was conducted and study outcomes included eradication rates and incidence of adverse events.

Conditions

Helicobacter Pylori Infection

Keywords

Helicobacter pylori; quadruple therapy

Outcome Measures

Primary Outcomes (1)

• Eradication rate

  Comparison of eradication rates among quadruple therapies for Helicobacter pylori

  6 weeks after treatment completion

Secondary Outcomes (1)

• Adverse events

  Immediately after treatment completion

Study Arms (2)

vonoprazan-based quadruple therapies

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

tegoprazan-based quadruple therapies

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.

tegoprazan-based quadruple therapies; vonoprazan-based quadruple therapies

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:

• patients aged 18-70 years, regardless of gender;
• absent history of receiving H. pylori eradication therapy;
• 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:

• 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;
• patients who received treatment regimens that did not comply with the quadruple regimens specified in this study.

Sponsors & Collaborators

• Yueyue Li: lead
• Qilu Hospital of Shandong University: collaborator
• Zaozhuang Municipal Hospital: collaborator
• Shandong University of Traditional Chinese Medicine: collaborator
• Qihe County People's Hospital: collaborator
• Taierzhuang District People's Hospital: collaborator
• University Town Hospital, Affiliated Hospital of Shandong University of Traditional Chinese Medicine: collaborator
• Dezhou Hospital 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: August 25, 2025
• First Posted: September 11, 2025
• Study Start: January 1, 2022
• Primary Completion: December 31, 2024
• Study Completion: July 31, 2025
• Last Updated: September 11, 2025

Record last verified: 2025-08

Locations

CN (1)