Omeprazole combined with amoxicillin and clarithromycin in the eradication of Helicobacter pylori in children with gastritis: A prospective randomized double-blind trial

J Pediatr. 2001 Nov;139(5):664-8. doi: 10.1067/mpd.2001.118197.

Abstract

Objectives: The aim of this multicenter prospective, randomized, double-blind study was to assess the efficacy of the combination of omeprazole, amoxicillin, and clarithromycin (OAC) for the treatment of Helicobacter pylori gastritis in children.

Study design: Seventy-three children with dyspeptic symptoms were included in the trial (mean age 10.8 years; range, 3.3 to 15.4). Patients were randomized to receive OAC or amoxicillin and clarithromycin (AC) for 7 days. H pylori status was assessed before and 4 weeks after eradication treatment, by use of the carbon 13-labeled urea breath test.

Results: In intent-to-treat analysis (n = 63), eradication rates were 74.2% (95% CI, 58.7 to 89.6) in the OAC group and 9.4% (95% CI, 0 to 19.5) in the AC group. In per-protocol analysis (n = 53), the eradication rate increased to 80% (95% CI, 64.3 to 95.7), remaining significantly higher than in AC group (10.7%; 95% CI, 0 to 22.2). Resistance of strains to clarithromycin was rare (3/39 = 7.7%) and was not associated with failure of treatment. Adverse events were reported in 24.6% of patients and remained mild.

Conclusion: This study shows that 1-week OAC triple therapy results in successful eradication of H pylori in 75% of children with gastritis.

Publication types

  • Clinical Trial
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Amoxicillin / therapeutic use*
  • Breath Tests
  • Child
  • Child, Preschool
  • Clarithromycin / therapeutic use*
  • Double-Blind Method
  • Drug Therapy, Combination
  • Female
  • Gastritis / drug therapy*
  • Gastritis / microbiology*
  • Helicobacter Infections / drug therapy*
  • Helicobacter pylori*
  • Humans
  • Male
  • Omeprazole / therapeutic use*
  • Prospective Studies
  • Treatment Outcome

Substances

  • Amoxicillin
  • Clarithromycin
  • Omeprazole