Study design
ADVERSE EVENTS, HEART, RECRUITMENT
This is a prospective, open-label, multicenter, randomized controlled trial. Eligible participants with Participants will be recruited from five Hallym University-affiliated hospitals (Hallym University Sacred Heart Hospital, Kangnam Sacred Heart Hospital, Dongtan Sacred Heart Hospital, Kangdong Sacred Heart Hospital, and Chuncheon Sacred Heart Hospital) during the recruitment period from January 2023 to June 2024. Personal interviews with open-ended questions via questionnaires and self-reporting will be conducted by telephone on day 7 or 14 after enrollment (completion of eradication regimen) to assess drug compliance and treatment-related adverse events. The interview window is two weeks. At their first visit post-regimen (four weeks after completion of the eradication regimen), we will assess eradication success and check for potential treatment-related adverse events and protocol violations.We had received approval from the MFDS in Korea and the IRB for human research at Hallym University-affiliated Hospital (No. 2021-09-013) before the study was initiated. This study was registered at cris.nih.go.kr in June 2022 (clinical trial registration number KCT0007444). The study protocol adheres to the CONSORT guidelines and Declaration of Helsinki as reflected in a priori endorsement by the institution’s human research committee. Written informed consent will be obtained before endoscopic examination.