Efficacy and Safety of P-CABs-Based Bismuth Quadruple Therapy for First-line Helicobacter Pylori Eradication: A Multicenter Cohort Study
| Registry | NCT07285096, acronym PRO-HP |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| Enrollment | 1730 (Estimated) |
| Sponsor | Yueyue Li (Other); collaborators: Qilu Hospital of Shandong University, Feicheng People's Hospital, Binzhou Maternal and Child Health Hospital, Jinxiang County People's Hospital, The People's Hospital of Jimo, Zibo Maternal and Child Health Hospital, Yantai Penglai Traditional Chinese Medicine Hospital, Zaozhuang Municipal Hospital, Linyi People's Hospital, Taierzhuang District People's Hospital, Shandong University of Traditional Chinese Medicine, Yuncheng Traditional Chinese Medicine Hospital, Caoxian County Hospital, Qihe County People's Hospital, Affiliated Hospital of Shandong University of Traditional Chinese Medicine, Dezhou Hospital Qilu Hospital of Shandong University, Dongying No. 2 People's Hospital, Zhangdian District Hospital of Traditional Chinese Medicine, Yantai Zhifu Hospital, Inner Mongolia People's Hospital, Hohhot Second Hospital, Guanxian County People's Hospital, Longkou People's Hospital, Linshu County Hospital of Traditional Chinese Medicine |
| Conditions | Helicobacter Pylori Infection |
| 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) |
| Dates | start 2025-12-16, primary completion 2026-06-01 (estimated), completion 2026-08-01 (estimated), first posted 2025-12-16, last updated 2025-12-23 |
| Locations | 1 site in China |
Related Papers Related Patents Related Grants Related Experts
All trials for Helicobacter Pylori Infection All trials of Doctors prescribe Helicobacter pylori treatment regimens for patients based on current guidelines and consensus statements, tailored to individual circumstances，not involve any intervention procedures
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| 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 |
Sex: All, ages: 18 Years to 70 Years
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.
| Facility | City | Country | Status |
|---|---|---|---|
| Qilu Hospital of Shandong University | Jinan | China | Recruiting |