A randomized, open trial evaluating the effect of Saccharomyces boulardii on the eradication rate of Helicobacter pylori infection in children.
OBJECTIVE
The failure rate of Helicobacter pylori (H. pylori) eradication imposes the assessment of new options.


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).


CONCLUSIONS
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.
Hurduc
Victoria
V
Department of Pediatric Gastroenterology, Victor Gomoiu University Children Hospital, Basarabia Street 21, Bucharest, Romania. v_hurduc@yahoo.com
Plesca
Doina
D
Dragomir
Dimitrie
D
Sajin
Maria
M
Vandenplas
Yvan
Y
D000293:Adolescent; D000658:Amoxicillin / Q000009:adverse effects / Q000627:therapeutic use; D000900:Anti-Bacterial Agents / Q000627:therapeutic use; D002648:Child; D002675:Child, Preschool; D017291:Clarithromycin / Q000009:adverse effects / Q000627:therapeutic use; D064098:Esomeprazole; D005260:Female; D016481:Helicobacter Infections / Q000188:drug therapy* / Q000628:therapy; D016480:Helicobacter pylori / Q000302:isolation & purification*; D006801:Humans; D008297:Male; D009853:Omeprazole / Q000009:adverse effects / Q000627:therapeutic use; D019936:Probiotics / Q000627:therapeutic use*; D011446:Prospective Studies; D054328:Proton Pump Inhibitors / Q000627:therapeutic use; D012440:Saccharomyces / Q000276:immunology*
D000900:Anti-Bacterial Agents; D054328:Proton Pump Inhibitors; D000658:Amoxicillin; D017291:Clarithromycin; D009853:Omeprazole; D064098:Esomeprazole