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).
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Nyssen Olga P, Jonaitis Laimas, Pérez-Aísa Ángeles, Tepes Bojan, Mahmudov Umud, Voynovan Irina, Martínez-Domínguez Samuel J, Bujanda Luis, Lucendo Alfredo J, Vologzanina Ludmila, Garre Ana, Lerang Frode, Abdulkhakov Sayar R, Pavoni Matteo, Denkovski Maja, Mammadov Emin, Leja Mārcis, Tejedor-Tejada Javier, Huguet Jose M, Fadieienko Galyna, Tatiana Ilchishina, Pabón-Carrasco Manuel, Sarsenbaeva Aiman S, Zaytsev Oleg, Babayeva Gülüstan, Barrio Jesús, Areia Miguel, Perona Monica, Núñez Óscar, Gravina Antonietta G, Alekseenko Sergey, Rodríguez Blas José Gómez, Oğlu Quliyev Fərid Vidadi, Ortiz-Polo Inmaculada, Loro Antonio Moreno, Buzás György Miklós, Starostin Boris D, Kupcinskas Juozas, Bordin Dmitry S, Gasbarrini Antonio, Gridnyev Oleksiy, Marcos-Pinto Ricardo, Jiménez-Moreno Manuel, Alonso Mónica Sánchez, Flores Virginia, Arteagoitia Irene, Cano-Català Anna, Parra Pablo, Moreira Leticia, Gisbert Javier P, Hp‐EuReg investigators
Аннотация
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.