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.


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 (109 colony-forming units) or placebo in 83 children with H pylori infection confirmed by 2 of 3 tests (13C-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.
Szajewska
Hania
H
2nd Department of Paediatrics, Medical University of Warsaw, Warsaw, Poland. hania@ipgate.pl
Albrecht
Piotr
P
Topczewska-Cabanek
Agnieszka
A