Saccharomyces boulardii CNCM I-745 plus sequential therapy for Helicobacter pylori infections: a randomized, open-label trial

• Published in: European journal of clinical pharmacology 2019-05, Vol.75 (5), p.639-645
• Main Authors: Seddik, Hassan, Boutallaka, Hanae, Elkoti, Ilham, Nejjari, Fouad, Berraida, Reda, Berrag, Sanaa, Loubaris, Khaoula, Sentissi, Sara, Benkirane, Ahmed
• Format: Article
• Language: English
• Subjects: Adult; Amoxicillin; Amoxicillin - adverse effects; Amoxicillin - therapeutic use; Anti-Bacterial Agents - adverse effects; Anti-Bacterial Agents - therapeutic use; Antibiotics; Biomedical and Life Sciences; Biomedicine; Clarithromycin; Clarithromycin - adverse effects; Clarithromycin - therapeutic use; Clinical Trial; Diarrhea; Eradication; Female; Helicobacter Infections - drug therapy; Helicobacter Infections - therapy; Helicobacter pylori; Helicobacter pylori - drug effects; Humans; Incidence; Infections; Male; Metronidazole; Metronidazole - adverse effects; Metronidazole - therapeutic use; Middle Aged; Omeprazole; Omeprazole - adverse effects; Omeprazole - therapeutic use; Pathogens; Patient compliance; Patients; Pharmacology/Toxicology; Probiotics - therapeutic use; Prospective Studies; Proton Pump Inhibitors - adverse effects; Proton Pump Inhibitors - therapeutic use; Random Allocation; Randomization; Saccharomyces; Saccharomyces boulardii
• ISSN: 0031-6970; 1432-1041
• DOI: 10.1007/s00228-019-02625-0

Aim To determine the effect of Saccharomyces boulardii CNCM I-745 ( S. boulardii ) plus sequential therapy on Helicobacter pylori ( H. pylori ) eradication rate. Methods This open-label prospective study randomized (1:1) patients with confirmed H. pylori infection to standard sequential therapy of twice-daily (bid) omeprazole 20 mg plus amoxicillin 1 g for 5 days, followed by bid omeprazole 20 mg, clarithromycin 500 mg and metronidazole 500 mg for the next 5 days (control group), or sequential therapy plus bid S. boulardii 250 mg (experimental group). Adverse events (AEs) were recorded throughout the study, and the H. pylori eradication rate was determined 4 weeks after treatment. Results The study was conducted from May 2013 to May 2016 and included 199 patients (51.3% male; mean age 44.6 ± 13.6 years). The H. pylori eradication rate was higher in the experimental group than the control group (86.0% vs. 74.7%; P =  0.02). Compared with the control group, patients in the experimental group experienced a significantly lower overall incidence of AEs (17.0% vs. 55.7%; p