P-CABs-based Bismuth Quadruple Therapy for Helicobacter Pylori Eradication (PRO-HP)

Efficacy and Safety of P-CABs-Based Bismuth Quadruple Therapy for First-line Helicobacter Pylori Eradication: A Multicenter Cohort Study

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.

Study Overview

• Status: Recruiting
• Conditions: Helicobacter Pylori Infection
• Intervention / Treatment: 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

• Study Type: Observational
• Enrollment (Estimated): 1730

Contacts and Locations

• Study Contact: Name: Yueyue Li; Phone Number: +8618560089751; Email: lyynqj@126.com

Study Locations

• China
  • Jinan, China
    • Recruiting
    • Qilu Hospital of Shandong University
    • Contact: Yueyue Li; Phone Number: +8618560089751; Email: lyynqj@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Eradication rate	Comparison of eradication rates among quadruple therapies for Helicobacter pylori	6-8 weeks after treatment completion

Secondary Outcome Measures

Outcome Measure	Time Frame
Adverse events	lmmediately after treatment completion

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): December 16, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): August 1, 2026

Study Registration Dates

• First Submitted: November 27, 2025
• First Submitted That Met QC Criteria: December 3, 2025
• First Posted (Estimated): December 16, 2025

Study Record Updates

• Last Update Posted (Actual): December 23, 2025
• Last Update Submitted That Met QC Criteria: December 20, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Helicobacter pylori; quadruple therapy
• Other Study ID Numbers: 202511

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No