Saccharomyces boulardii CNCM I-745 plus sequential therapy for Helicobacter pylori infections: a randomized, open-label trial
Abstract
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 < 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).Conclusion 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.
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S. boulardii-based products lacked detectable ARGs or virulence factors while exhibiting intrinsic, non-transferable antibiotic resistance, supporting a comparatively favorable safety profile in high-risk clinical settings.
“In contrast to bacterial probiotics, S. boulardii–based products lacked detectable ARGs or virulence factors while exhibiting intrinsic, non-transferable antibiotic resistance, supporting a comparatively favorable safety profile in high-risk clinical settings.4,9,36,37”
From Safety and efficacy concerns in Indian probiotics: Insights from whole-genome sequencing and <i>in vitro</i> assessment (2026) · cites this paper as [37]
Clinical studies have previously established S. boulardii's efficacy in reducing diarrhea duration in pediatric and adult populations, particularly in the context of antibiotic-associated diarrhea, Helicobacter pylori, and Clostridioides difficile infections.
“Clinical studies have previously established S. boulardii's efficacy in reducing diarrhea duration in pediatric and adult populations, particularly in the context of AAD, Helicobacter pylori, and Clostridioides difficile infections.9,36,37”
From Safety and efficacy concerns in Indian probiotics: Insights from whole-genome sequencing and <i>in vitro</i> assessment (2026) · cites this paper as [37]
S. boulardii CNCM I-745 (Econorm) significantly enhanced Helicobacter pylori eradication rates (86.0% vs. 74.7%, p = 0.02) and reduced antibiotic-associated diarrhea (2.0% vs. 46.4%, p = 0.02), while improving treatment adherence (95.0% vs. 91.2%, p < 0.001).
“For instance, S. boulardii CNCM I-745 (Econorm) significantly enhanced Helicobacter pylori eradication rates (86.0% vs. 74.7%, p = 0.02) and reduced antibiotic-associated diarrhea (AAD) (2.0% vs. 46.4%, p = 0.02), while improving treatment adherence (95.0% vs. 91.2%, p < 0.001).37”
From Safety and efficacy concerns in Indian probiotics: Insights from whole-genome sequencing and <i>in vitro</i> assessment (2026) · cites this paper as [37]
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- Authors
- Seddik, H., Boutallaka, H., Elkoti, I., Nejjari, F., Berraida, R., Berrag, S., Loubaris, K., Sentissi, S., & Benkirane, A.
- Affiliations
- Mohammed V University (MA)
- Corresponding author
- Boutallaka, Hanae
- Venue
- European Journal of Clinical Pharmacology
- Published
- 2019-01-29
- Volume
- 75
- Issue
- 5
- Pages
- 639-645
- ISSN
- 0031-6970 (ISSN-L)
- 1432-1041
- OpenAlex
- W2913971352
- Cited by
- 41
- References
- 36
- Citations by year
- 2026: 4 · 2025: 4 · 2024: 14 · 2023: 6 · 2022: 5 · 2021: 5 · 2020: 2 · 2019: 1
- FWCI
- 3.10
- Type
- journal article
- Language
- en
- Open access
- closed
- Licence
- www.springer.com/tdm (tdm)
- Locations
- European Journal of Clinical Pharmacology (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Surgery › Helicobacter pylori-related gastroenterology studies
- Life Sciences › Agricultural and Biological Sciences › Food Science › Probiotics and Fermented Foods
- Health Sciences › Medicine › Gastroenterology › Gastrointestinal motility and disorders
- Keywords
- Saccharomyces boulardii, Helicobacter pylori infection, Helicobacter pylori eradication, sequential therapy, probiotics, antibiotic-associated diarrhea, adverse events, medication adherence, omeprazole, amoxicillin, clarithromycin, metronidazole
- MeSH terms
- Saccharomyces boulardii, Adult, Amoxicillin, Anti-Bacterial Agents, Female, Humans, Male, Metronidazole, Middle Aged, Omeprazole, Prospective Studies, Random Allocation, Helicobacter pylori, Helicobacter Infections, Clarithromycin, Probiotics, Proton Pump Inhibitors
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