Randomized, Double-blind, Placebo-controlled Trial: Effect of Lactobacillus GG Supplementation on Helicobacter Pylori Eradication Rates and Side Effects During Treatment in Children

Objective: To determine the effectiveness of Lactobacillus GG (LGG) in children with Helicobacter pylori infection undergoing eradication therapy. Materials and Methods: We conducted a double-blind, placebo-controlled, randomized trial comparing a 7-day, triple eradication regimen consisting of 2 antibiotics (amoxicillin tablets, 25 mg/kg twice per day, and clarithromycin tablets, 10 mg/kg twice per day) plus a proton pump inhibitor (omeprazole capsules, 0.5 mg/kg twice per day) supplemented with LGG (10(9) colony-forming units) or placebo in 83 children with H pylori infection confirmed by 2 of 3 tests (C-13-urea breath test, histopathology, rapid urease test). The primary outcome measure was the H pylori eradication rate. The secondary outcome measure was the proportion of patients who experienced therapy-related adverse effects during anti-H pylori treatment. Results: The groups did not differ with respect to H pylori eradication rates. Of the 34 children in the LGG group, 23 (69%) experienced eradication, compared with 22 of 32 children (68%) in the placebo group (RR 0.98, 95% CI 0.7-1.4). The groups did not differ with respect to adverse effects. Conclusions: In children with H pylori infection, supplementation of standard triple therapy with LGG did not significantly alter the eradication rate or side effects. JPGN 48:431-436, 2009.