P-CABs-based Bismuth Quadruple Therapy for Helicobacter Pylori Eradication

NCT07285096 | Recruiting

• 1 other identifier: 202511
• 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 potassium-competitive acid blockers (P-CABs) -based bismuth quadruple regimens and identify factors influencing treatment failure. A multicenter cohort study 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

  6-8 weeks after treatment completion

Secondary Outcomes (1)

• Adverse events

  lmmediately after treatment completion

Study Arms (2)

vonoprazan-based quadruple therapies

Other: Doctors prescribe Helicobacter pylori treatment regimens for patients based on current guidelines and consensus statements, tailored to individual circumstances，not involve any intervention procedures

tegoprazan-based quadruple therapies

Other: Doctors prescribe Helicobacter pylori treatment regimens for patients based on current guidelines and consensus statements, tailored to individual circumstances，not involve any intervention procedures

Interventions

Doctors prescribe Helicobacter pylori treatment regimens for patients based on current guidelines and consensus statements, tailored to individual circumstances，not involve any intervention procedures OTHER

Doctors prescribe Helicobacter pylori treatment regimens for patients based on current guidelines and consensus statements, tailored to individual circumstances，not involve any intervention procedures.

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) willing to receive 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;
• willing to receive 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

• Binzhou Maternal and Child Health Hospital: collaborator
• Zaozhuang Municipal Hospital: collaborator
• Yuncheng Traditional Chinese Medicine Hospital: collaborator
• Yantai Zhifu Hospital: collaborator
• Inner Mongolia Autonomous Region International Mongolian Medicine Hospital: collaborator
• Guanxian People's Hospital: collaborator
• Qilu Hospital of Shandong University: collaborator
• Feicheng People's Hospital: collaborator
• Jinxiang County People's Hospital: collaborator
• The People's Hospital of Jimo: collaborator
• Zibo Maternal and Child Health Hospital: collaborator
• Yantai Penglai Traditional Chinese Medicine Hospital: collaborator
• Linyi Yizhou Hospital: collaborator
• Taierzhuang District People's Hospital: collaborator
• Shandong University of Traditional Chinese Medicine: collaborator
• Caoxian County Hospital: collaborator
• The 2nd People's Hospital of Dongying City: collaborator
• Zhangdian District Hospital of Traditional Chinese Medicine: collaborator
• Hohhot Second Hospital: collaborator
• Longkou People's Hospital: collaborator
• Linshu County Hospital of Traditional Chinese Medicine: collaborator
• Yueyue Li: lead
• Qihe County 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, China

RECRUITING

Central Study Contacts

Yueyue Li

CONTACT

+8618560089751; lyynqj@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 8 Weeks
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 27, 2025
• First Posted: December 16, 2025
• Study Start: December 16, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: December 23, 2025

Record last verified: 2025-12

Locations

CN (1)