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 Abdulkhakov, Matteo Pavoni, Maja Denkovski, Emin Vagif Mammadov, M ̄arcis Leja, Javier Tejedor‐Tejada, Jose M. Huguet, G. D. Fadieienko, Ilchishina Tatiana, Manuel Pabón‐Carrasco, Aiman S. Sarsenbaeva, Oleg Zaytsev, Gülüstan Babayeva, Jesús Barrio, Miguel Areia, Mónica Perona, Óscar Núñez, Antonietta Gerarda 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, D. S. Bordin, A. Gasbarrini, Oleksiy Gridnyev, Ricardo Marcos‐Pinto, Manuel Jiménez‐Moreno, Mónica Sánchez Alonso, Virginia Flores, Irene Arteagoitia, Anna Cano‐Català, P Parra, Leticia Moreira, Javier P. Gisbert, the Hp‐EuReg investigators
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. REGISTRATION NUMBER: ClinicalTrials.gov identifier: NCT02328131.