Saccharomyces boulardii CNCM I-745 plus sequential therapy for Helicobacter pylori infections: a randomized, open-label trial
To determine the effect of Saccharomyces boulardii CNCM I-745 (S. boulardii) plus sequential therapy on Helicobacter pylori (H. pylori) eradication rate.
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.
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 < 0.001) and the incidence of antibiotic-associated diarrhea (2.0% vs. 46.4%; P = 0.02). The experimental group showed improved treatment compliance over the 10-day study period compared with the control group (95.0% vs. 91.2%, P < 0.001).
Addition of S. boulardii to sequential therapy improved H. pylori eradication rate and reduced the incidence of treatment-associated AEs in Moroccan patients with H. pylori infection.
KeywordsAntibiotic-induced diarrhea Helicobacter pylori H. pylori eradication rate Saccharomyces boulardii Sequential treatment Treatment compliance
The authors thank Nishad Parkar, PhD, of Springer Healthcare Communications for technical and English editing of the manuscript prior to submission. This medical writing assistance was funded by Biocodex.
Hassan Seddik was responsible for study concept and planning and supervised the statistical analysis and redaction of the manuscript. Hanae Boutallaka was involved in performing the statistical analysis and writing the manuscript, with input from all authors. Fouad Nejjari, Reda Berraida, Khaoula Loubaris, Ilham Elkoti, Sanaa Berrag and Sara Sentissi were involved in patient enrollment and data collection and were involved in the preparation of the manuscript. Ahmed Benkirane was involved in conducting and supervising the study.
Support was provided by Biocodex, France.
Compliance with ethical standards
Informed consent statement
All patients included in the study provided written informed consent before the study commenced.
Conflict of interest
The authors have no conflicts of interest to declare.
CONSORT 2010 statement
The authors have read the CONSORT 2010 Statement, and the manuscript was prepared and revised according to the CONSORT 2010 Statement.
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