Probiotics for the Treatment of Pediatric Helicobacter Pylori Infection: A Randomized Double Blind Clinical Trial

OBJECTIVE Helicobacter pylori is recognized as a major etiological factor in the pathogenesis of gastritis and peptic ulcer disease. H. Pylori eradication has a failure rate of more than 30% in pediatric patients, particularly because of poor compliance, antibiotic resistance and occurrence of side-effects. This study was aimed to determine whether adding the probiotics to a standard anti-H. pylori regimen could minimize the gastrointestinal side-effect prevalence and improve the eradication rate. METHODS Double-blind randomized placebo controlled study conducted at Children's Medical Center in Tehran, Iran. Sixty six H. pylori positive children were treated with a triple drug treatment protocol (omeprazole+amoxycillin+furazolidon) and randomly allocated to receive either probiotic or placebo. All patients underwent esophagogastroduodendoscopy. H. pylori infection was diagnosed by either rapid urease test (RUT) or histology. H. pylori status was assessed after 4-8 weeks of the completion of treatment with stool H. pylori antigen test. The side effects of the treatment were determined in each group. FINDINGS Mean age of patients was 9.09 (range 3-14) years, 44 (65.7%) patients were boys (sex ratio 2:1). All 66 patients completed the course of treatment and follow-up. The rate of H. pylori eradication was significantly higher in probiotic group (P=0.04). In probiotic supplemented children there was a lower rate of nausea/vomiting (P=0.02) and diarrhea (P=0.039) during treatment. CONCLUSION This study showed that probiotics have positive effect on the eradication of H. pylori infection. Adjuvant therapy with probiotic is recommended in order to reduce the frequency of antibiotic induced side-effects during treatment with antibiotics.