Olga P. Nyssen, Laimas Jonaitis, Ángeles Pérez-Aísa, Bojan Tepes, Umud Mahmudov, Irina Voynovan, Samuel J. Martínez-Domínguez, Luis Bujanda, Alfredo J. Lucendo, Ludmila Vologzanina, Ana Garre, Frode Lerang, Sayar R. Abdulkhakov, Matteo Pavoni, Maja Denkovski, Emin Mammadov, Mārcis Leja, Javier Tejedor-Tejada, Jose M. Huguet, Galyna Fadieienko, Ilchishina Tatiana, Manuel Pabón-Carrasco, Aiman S. Sarsenbaeva, Oleg Zaytsev, Gülüstan Babayeva, Jesús Barrio, Miguel Areia, Monica Perona, Óscar Núñez, Antonietta G. Gravina, Sergey Alekseenko, Blas José Gómez Rodríguez, Quliyev Fərid Vidadi Oğlu, Inmaculada Ortiz-Polo, Antonio Moreno Loro, György Miklós Buzás, Boris D. Starostin, Juozas Kupcinskas, Dmitry S. Bordin, Antonio Gasbarrini, Oleksiy Gridnyev, Ricardo Marcos-Pinto, Manuel Jiménez-Moreno, Mónica Sánchez Alonso, Virginia Flores, Irene Arteagoitia, Anna Cano-Català, Pablo Parra, Leticia Moreira, Javier P. Gisbert, the Hp-EuReg investigators
{"title":"博氏酵母CNCM I-745作为幽门螺杆菌根除辅助治疗的实际有效性和安全性：来自欧洲幽门螺杆菌管理登记处（Hp-EuReg）的数据。","authors":"Olga P. Nyssen, Laimas Jonaitis, Ángeles Pérez-Aísa, Bojan Tepes, Umud Mahmudov, Irina Voynovan, Samuel J. Martínez-Domínguez, Luis Bujanda, Alfredo J. Lucendo, Ludmila Vologzanina, Ana Garre, Frode Lerang, Sayar R. Abdulkhakov, Matteo Pavoni, Maja Denkovski, Emin Mammadov, Mārcis Leja, Javier Tejedor-Tejada, Jose M. Huguet, Galyna Fadieienko, Ilchishina Tatiana, Manuel Pabón-Carrasco, Aiman S. Sarsenbaeva, Oleg Zaytsev, Gülüstan Babayeva, Jesús Barrio, Miguel Areia, Monica Perona, Óscar Núñez, Antonietta G. Gravina, Sergey Alekseenko, Blas José Gómez Rodríguez, Quliyev Fərid Vidadi Oğlu, Inmaculada Ortiz-Polo, Antonio Moreno Loro, György Miklós Buzás, Boris D. Starostin, Juozas Kupcinskas, Dmitry S. Bordin, Antonio Gasbarrini, Oleksiy Gridnyev, Ricardo Marcos-Pinto, Manuel Jiménez-Moreno, Mónica Sánchez Alonso, Virginia Flores, Irene Arteagoitia, Anna Cano-Català, Pablo Parra, Leticia Moreira, Javier P. Gisbert, the Hp-EuReg investigators","doi":"10.1111/hel.70119","DOIUrl":null,"url":null,"abstract":"<div>\n \n \n <section>\n \n <h3> Background</h3>\n \n <p><i>Saccharomyces boulardii</i> CNCM I-745 (Sb) is one of the most widely used probiotics in clinical practice. The aim of this study was to assess the impact of adding Sb to <i>Helicobacter pylori</i> eradication therapy on treatment outcomes (effectiveness and safety) in routine European gastroenterology clinical practice.</p>\n </section>\n \n <section>\n \n <h3> Materials and Methods</h3>\n \n <p>Treatment-naive cases from the European registry on <i>H. pylori</i> management (Hp-EuReg) collected from 2013 to 2023 at AEG-REDCap were analyzed. Effectiveness was assessed by modified intention-to-treat, by treatment and geographic regions. Multivariate analysis identified factors independently associated with eradication success and adverse event incidence.</p>\n </section>\n \n <section>\n \n <h3> Results</h3>\n \n <p>Among 69,922 cases, probiotics were used in 16,528 (24%) treatments, of which 4404 (27%) included Sb. Sb use was significantly associated with an increase in effectiveness (OR = 2.32; 95% confidence interval, 1.38–4.03; <i>p</i> < 0.01) only when prescribed with concomitant therapy encompassing a proton pump inhibitor plus clarithromycin-amoxicillin-metronidazole. In addition, a significant reduction in the overall incidence of at least one adverse event was observed in the Sb group (OR = 0.803; 0.66–0.97; <i>p</i> < 0.05). Specifically, diarrhea, nausea, dyspepsia, abdominal pain, asthenia, anorexia, heartburn, and dysgeusia occurred significantly less frequently with Sb. Treatment compliance was high in both groups (with and without Sb).</p>\n </section>\n \n <section>\n \n <h3> Conclusions</h3>\n \n <p>In Europe, the addition of Sb to first-line regimens in clinical practice was associated with higher effectiveness when combined with concomitant therapy with clarithromycin-amoxicillin-metronidazole and with fewer overall adverse events, supporting its role as a beneficial adjunct in <i>H. pylori</i> eradication therapy.</p>\n </section>\n \n <section>\n \n <h3> Registration Number</h3>\n \n <p>ClinicalTrials.gov identifier: NCT02328131</p>\n </section>\n </div>","PeriodicalId":13223,"journal":{"name":"Helicobacter","volume":"31 2","pages":""},"PeriodicalIF":4.3000,"publicationDate":"2026-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13043801/pdf/","citationCount":"0","resultStr":"{\"title\":\"Real-World Effectiveness and Safety of Saccharomyces boulardii CNCM I-745 as Adjunct Therapy for Helicobacter pylori Eradication: Data From the European Registry on H. pylori Management (Hp-EuReg)\",\"authors\":\"Olga P. Nyssen, Laimas Jonaitis, Ángeles Pérez-Aísa, Bojan Tepes, Umud Mahmudov, Irina Voynovan, Samuel J. Martínez-Domínguez, Luis Bujanda, Alfredo J. Lucendo, Ludmila Vologzanina, Ana Garre, Frode Lerang, Sayar R. Abdulkhakov, Matteo Pavoni, Maja Denkovski, Emin Mammadov, Mārcis Leja, Javier Tejedor-Tejada, Jose M. Huguet, Galyna Fadieienko, Ilchishina Tatiana, Manuel Pabón-Carrasco, Aiman S. Sarsenbaeva, Oleg Zaytsev, Gülüstan Babayeva, Jesús Barrio, Miguel Areia, Monica Perona, Óscar Núñez, Antonietta G. Gravina, Sergey Alekseenko, Blas José Gómez Rodríguez, Quliyev Fərid Vidadi Oğlu, Inmaculada Ortiz-Polo, Antonio Moreno Loro, György Miklós Buzás, Boris D. Starostin, Juozas Kupcinskas, Dmitry S. Bordin, Antonio Gasbarrini, Oleksiy Gridnyev, Ricardo Marcos-Pinto, Manuel Jiménez-Moreno, Mónica Sánchez Alonso, Virginia Flores, Irene Arteagoitia, Anna Cano-Català, Pablo Parra, Leticia Moreira, Javier P. 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Real-World Effectiveness and Safety of Saccharomyces boulardii CNCM I-745 as Adjunct Therapy for Helicobacter pylori Eradication: Data From the European Registry on H. pylori Management (Hp-EuReg)
Background
Saccharomyces boulardii CNCM I-745 (Sb) is one of the most widely used probiotics in clinical practice. The aim of this study was to assess the impact of adding Sb to Helicobacter pylori eradication therapy on treatment outcomes (effectiveness and safety) in routine European gastroenterology clinical practice.
Materials and Methods
Treatment-naive cases from the European registry on H. pylori management (Hp-EuReg) collected from 2013 to 2023 at AEG-REDCap were analyzed. Effectiveness was assessed by modified intention-to-treat, by treatment and geographic regions. Multivariate analysis identified factors independently associated with eradication success and adverse event incidence.
Results
Among 69,922 cases, probiotics were used in 16,528 (24%) treatments, of which 4404 (27%) included Sb. Sb use was significantly associated with an increase in effectiveness (OR = 2.32; 95% confidence interval, 1.38–4.03; p < 0.01) only when prescribed with concomitant therapy encompassing a proton pump inhibitor plus clarithromycin-amoxicillin-metronidazole. In addition, a significant reduction in the overall incidence of at least one adverse event was observed in the Sb group (OR = 0.803; 0.66–0.97; p < 0.05). Specifically, diarrhea, nausea, dyspepsia, abdominal pain, asthenia, anorexia, heartburn, and dysgeusia occurred significantly less frequently with Sb. Treatment compliance was high in both groups (with and without Sb).
Conclusions
In Europe, the addition of Sb to first-line regimens in clinical practice was associated with higher effectiveness when combined with concomitant therapy with clarithromycin-amoxicillin-metronidazole and with fewer overall adverse events, supporting its role as a beneficial adjunct in H. pylori eradication therapy.
期刊介绍：
Helicobacter is edited by Professor David Y Graham. The editorial and peer review process is an independent process. Whenever there is a conflict of interest, the editor and editorial board will declare their interests and affiliations. Helicobacter recognises the critical role that has been established for Helicobacter pylori in peptic ulcer, gastric adenocarcinoma, and primary gastric lymphoma. As new helicobacter species are now regularly being discovered, Helicobacter covers the entire range of helicobacter research, increasing communication among the fields of gastroenterology; microbiology; vaccine development; laboratory animal science.
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