A randomized, open trial evaluating the effect of Saccharomyces boulardii on the eradication rate of Helicobacter pylori infection in children
Article first published online: 4 AUG 2008
©2008 The Author(s)/Journal Compilation ©2008 Foundation Acta Pædiatrica/Acta Pædiatrica
Volume 98, Issue 1, pages 127–131, January 2009
How to Cite
Hurduc, V., Plesca, D., Dragomir, D., Sajin, M. and Vandenplas, Y. (2009), A randomized, open trial evaluating the effect of Saccharomyces boulardii on the eradication rate of Helicobacter pylori infection in children. Acta Paediatrica, 98: 127–131. doi: 10.1111/j.1651-2227.2008.00977.x
- Issue published online: 9 DEC 2008
- Article first published online: 4 AUG 2008
- Received 6 May 2008; revised 30 June 2008; accepted 9 July 2008
- Helicobacter pylori;
- Saccharomyces boulardii;
- Triple therapy
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.