title: A randomized, open trial evaluating the effect of Saccharomyces boulardii on the eradication rate of Helicobacter pylori infection in children.
abstract: 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.
authors.affiliation: Department of Pediatric Gastroenterology, Victor Gomoiu University Children Hospital, Basarabia Street 21, Bucharest, Romania. v_hurduc@yahoo.com
authors.forename: Victoria
authors.initials: V
authors.lastname: Hurduc
authors.forename: Doina
authors.initials: D
authors.lastname: Plesca
authors.forename: Dimitrie
authors.initials: D
authors.lastname: Dragomir
authors.forename: Maria
authors.initials: M
authors.lastname: Sajin
authors.forename: Yvan
authors.initials: Y
authors.lastname: Vandenplas
mesh_terms: 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*
chemical_list: D000900:Anti-Bacterial Agents; D054328:Proton Pump Inhibitors; D000658:Amoxicillin; D017291:Clarithromycin; D009853:Omeprazole; D064098:Esomeprazole