{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,30]],"date-time":"2026-06-30T04:47:01Z","timestamp":1782794821351,"version":"3.54.5"},"reference-count":23,"publisher":"Wiley","issue":"3","license":[{"start":{"date-parts":[[2026,6,8]],"date-time":"2026-06-08T00:00:00Z","timestamp":1780876800000},"content-version":"vor","delay-in-days":38,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"},{"start":{"date-parts":[[2026,5,1]],"date-time":"2026-05-01T00:00:00Z","timestamp":1777593600000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Helicobacter"],"published-print":{"date-parts":[[2026,5]]},"abstract":"ABSTRACT<\/jats:title>\n \n Background\/Aims<\/jats:title>\n \n The eradication efficacy of proton pump inhibitor (PPI)\u2013based standard triple therapy (STT) for\n \n Helicobacter pylori<\/jats:italic>\n <\/jats:styled-content>\n infection has declined in Korea, largely because of increasing clarithromycin resistance. High\u2010dose dual therapy (HDDT) using potent acid suppression represents a promising clarithromycin\u2010sparing strategy. This study evaluated the efficacy and safety of fexuprazan\u2010based modified HDDT (m\u2010HDDT) including bismuth, compared with conventional PPI\u2010based STT as first\u2010line eradication therapy.\n <\/jats:p>\n <\/jats:sec>\n \n Methods<\/jats:title>\n \n This prospective, multicenter, randomized, open\u2010label, non\u2010inferiority trial was conducted at eight tertiary hospitals in Korea. Treatment\u2010na\u00efve adults with confirmed\n \n H. pylori<\/jats:italic>\n <\/jats:styled-content>\n infection were randomized to receive either m\u2010HDDT (fexuprazan 40\u2009mg twice daily, amoxicillin 1000\u2009mg three times daily, and bismuth subcitrate potassium 300\u2009mg three times daily) or STT (lansoprazole 30\u2009mg, amoxicillin 1000\u2009mg, and clarithromycin 500\u2009mg, all twice daily) for 14\u2009days. Eradication was assessed by urea breath test 4\u20138\u2009weeks after therapy. The primary endpoint was the eradication rate in the full analysis set (FAS), with a prespecified non\u2010inferiority margin of \u221210%. Safety and compliance were evaluated as secondary outcomes.\n <\/jats:p>\n <\/jats:sec>\n \n Results<\/jats:title>\n \n In total, 196 patients were included in the FAS (m\u2010HDDT,\n n<\/jats:italic>\n \u2009=\u200996; STT,\n n<\/jats:italic>\n \u2009=\u2009100).\n \n Helicobacter pylori<\/jats:italic>\n <\/jats:styled-content>\n eradication was achieved in 81.3% of patients in the m\u2010HDDT group and 79.0% in the STT group, demonstrating non\u2010inferiority of m\u2010HDDT (one\u2010sided Wald test,\n p<\/jats:italic>\n \u2009=\u20090.0158). Per\u2010protocol analysis yielded consistent results (\n p<\/jats:italic>\n \u2009=\u20090.0215). Drug compliance was high in both groups, with mean compliance rates of 97.0% in the m\u2010HDDT group and 99.0% in the STT group; more than 95% of patients in each group achieved \u2265\u200980% compliance. The incidence of treatment\u2010emergent adverse events was comparable between groups (16.7% vs. 14.0%); most events consisted of mild gastrointestinal symptoms. No serious adverse events or treatment discontinuations due to adverse events were observed in either group.\n <\/jats:p>\n <\/jats:sec>\n \n Conclusions<\/jats:title>\n \n Fexuprazan\u2010based m\u2010HDDT with bismuth was non\u2010inferior to PPI\u2010based STT for\n \n H. pylori<\/jats:italic>\n <\/jats:styled-content>\n eradication and demonstrated comparable safety and excellent compliance. This clarithromycin\u2010sparing regimen can be considered an alternative treatment option in regions with high macrolide resistance.\n <\/jats:p>\n <\/jats:sec>","DOI":"10.1111\/hel.70146","type":"journal-article","created":{"date-parts":[[2026,6,8]],"date-time":"2026-06-08T09:12:56Z","timestamp":1780909976000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Efficacy and Safety of Fexuprazan\u2010Based Modified High\u2010Dose Dual Therapy for\n \n Helicobacter pylori<\/i>\n <\/scp>\n Eradication: A Randomized Clinical Trial"],"prefix":"10.1111","volume":"31","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-0030-3744","authenticated-orcid":false,"given":"Ji Yong","family":"Ahn","sequence":"first","affiliation":[{"name":"Division of Gastroenterology, Department of Internal Medicine University of Ulsan College of Medicine, Asan Medical Center Seoul Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4004-6292","authenticated-orcid":false,"given":"Ki\u2010Nam","family":"Shim","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine Ewha Womans University College of Medicine Seoul Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8367-4371","authenticated-orcid":false,"given":"Jung\u2010Ho","family":"Park","sequence":"additional","affiliation":[{"name":"Department of Medicine Sungkyunkwan University School of Medicine, Kangbuk Samsung Hospital Seoul South Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1799-9028","authenticated-orcid":false,"given":"Sang Gyun","family":"Kim","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine and Liver Research Institute Seoul National University College of Medicine Seoul Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2503-2688","authenticated-orcid":false,"given":"Jeong Hwan","family":"Kim","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine Konkuk University School of Medicine Seoul Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5909-8159","authenticated-orcid":false,"given":"Jeong Seop","family":"Moon","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine Sanggye Paik Hospital, Inje University College of Medicine Seoul Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0071-229X","authenticated-orcid":false,"given":"Young Hoon","family":"Youn","sequence":"additional","affiliation":[{"name":"Division of Gastroenterology, Department of Internal Medicine Gangnam Severance Hospital, Yonsei University College of Medicine Seoul Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1161-8618","authenticated-orcid":false,"given":"Jae J","family":"Kim","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology Ujeongbu Eulji Medical Center Gyenggi\u2010do 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