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NCT Number: NCT07285096

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

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.

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Key information

Conditions

Helicobacter Pylori Infection

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Eradication rate

    Time frame: 6-8 weeks after treatment completion

    Comparison of eradication rates among quadruple therapies for Helicobacter pylori

Secondary outcomes

  1. Adverse events

    Time frame: lmmediately after treatment completion

Study contacts

Contact information is provided by the study sponsor or research team.

Yueyue Li

CONTACT

[email protected]

+8618560089751

Sponsors and collaborators

Lead sponsor

Yueyue Li

Other

Collaborators

  • Affiliated Hospital of Shandong University of Traditional Chinese Medicine
  • Binzhou Maternal and Child Health Hospital
  • Caoxian County Hospital
  • Dezhou Hospital Qilu Hospital of Shandong University
  • Dongying No. 2 People's Hospital
  • Feicheng People's Hospital
  • Guanxian County People's Hospital
  • Hohhot Second Hospital
  • Inner Mongolia People's Hospital
  • Jinxiang County People's Hospital
  • Linshu County Hospital of Traditional Chinese Medicine
  • Linyi Yizhou Hospital
  • Longkou People's Hospital
  • Qihe County People's Hospital
  • Qilu Hospital of Shandong University
  • Shandong University of Traditional Chinese Medicine
  • Taierzhuang District People's Hospital
  • The People's Hospital of Jimo
  • Yantai Penglai Traditional Chinese Medicine Hospital
  • Yantai Zhifu Hospital
  • Yuncheng Traditional Chinese Medicine Hospital
  • Zaozhuang Municipal Hospital
  • Zhangdian District Hospital of Traditional Chinese Medicine
  • Zibo Maternal and Child Health Hospital

Registry information

Official study title

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

Acronym: PRO-HP

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 16, 2025
Registry last updated
Dec 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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