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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07285096
Acronym
PRO-HP
Enrollment
1730
Registered
2025-12-16
Start date
2025-12-16
Completion date
2026-08-01
Last updated
2025-12-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Helicobacter Pylori Infection

Keywords

Helicobacter pylori, quadruple therapy

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.

Interventions

OTHERDoctors 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.

Sponsors

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

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Eradication rate6-8 weeks after treatment completionComparison of eradication rates among quadruple therapies for Helicobacter pylori

Secondary

MeasureTime frame
Adverse eventslmmediately after treatment completion

Countries

China

Contacts

Primary ContactYueyue Li
lyynqj@126.com+8618560089751

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026