A randomized, open trial evaluating the effect of Saccharomyces boulardii on the eradication rate of Helicobacter pylori infection in children

Aim: The failure rate of Helicobacter pylori (H. pylori) eradication imposes the assessment of new options. Subjects and methods: A prospective open study was performed in 90 symptomatic children (range 3-18 years) with H. pylori infection, randomized in two groups: control (42 patients) and intervention group (48 patients). Both groups were treated with the standard triple eradication therapy (omeprazole/esomeprazole, amoxicillin and clarithromycin) for 7-10 days. The intervention group was also treated with Saccharomyces boulardii (S. boulardii), 250 mg b.i.d., for 4 weeks. The eradication rate of H. pylori was assessed by the same methods (urease test and histology) 4-6 weeks after treatment. Adverse events and compliance were evaluated after 7 and 28 days of treatment. The Chi-square test was used for statistical evaluation (p < 0.05). Results: H. pylori infection was identified in 90 of 145 children (62%) and it correlated positively with age (p < 0.002) and inversely with socioeconomic status (p < 0.005). All infected children had chronic gastritis, with antral nodularity in 76.7%. Overall, H. pylori eradication rate was 87.7% (control 80.9%, S. boulardii group 93.3%) (p = 0.750). The incidence of side effects was reduced in the S. boulardii group: 30.9% in the control versus 8.3% in the probiotic group (p = 0.047). Conclusion: The addition of S. boulardii to the standard eradication treatment confers a 12% nonsignificant enhanced therapeutic benefit on H. pylori eradication and reduces significantly the incidence of side effects.