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

2019-01-29
European journal of clinical pharmacology 75(5)
- Hassan Seddik
- Hanae Boutallaka
- Ilham Elkoti
- Fouad Nejjari
- Reda Berraida
- Sanaa Berrag
- Khaoula Loubaris
- Sara Sentissi
- Ahmed Benkirane

PubMed: 30694338
DOI: 10.1007/s00228-019-02625-0

Study Design

Type: Randomized Controlled Trial (RCT)
Sample size: n = 199
Population: 199 patients (51.3% male; mean age 44.6±13.6 years) with H. pylori infection
Methods: Open-label prospective study randomized (1:1) to standard sequential therapy (omeprazole 20mg plus amoxicillin 1g bid for 5 days, then omeprazole 20mg, clarithromycin 500mg, and metronidazole 500mg bid for 5 days) or sequential therapy plus S. boulardii 250mg bid
Blinding: Open-label
Duration: 10-day study period

Large Human Trial

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.

Research Insights

Saccharomyces boulardii→Increased Helicobacter pylori Eradication Rate
The H. pylori eradication rate was higher in the experimental group than the control group (86.0% vs. 74.7%; P = 0.02).
Effect
Beneficial
Effect size
Small
Dose
250 mg twice daily

Adverse Events Reported

Saccharomyces boulardii→Overall tolerability
patients in the experimental group experienced a significantly lower overall incidence of AEs (17.0% vs. 55.7%; p < 0.001)
Finding
Reported
Saccharomyces boulardii→antibiotic-associated diarrhea
the incidence of antibiotic-associated diarrhea (2.0% vs. 46.4%; P = 0.02)
Finding
Reported
Magnitude
2.0% vs. 46.4%
Significant
Yes