A randomized double-blind placebo-controlled trial of Lactobacillus GG for abdominal pain disorders in children.

BACKGROUND Functional abdominal pain disorders (FAPD) are common in school-aged children; however, there is no reliable treatment. AIM To determine the efficacy of Lactobacillus rhamnosus GG (LGG) for treating FAPD in children. METHODS A total of 104 children who fulfilled the Rome II criteria for functional dyspepsia (FD), or irritable bowel syndrome (IBS), or functional abdominal pain (FAP) were enrolled in a double-blind, randomized controlled trial in which they received LGG (n = 52), or placebo (n = 52) for 4 weeks. RESULTS For the overall study population, those in the LGG group were more likely to have treatment success (no pain) than those in the placebo group (25% vs. 9.6%, relative benefit (RB) 2.6, 95% confidence interval (CI): 1.05-6.6, number needed to treat (NNT) 7, 95% CI: 4-123). For children with IBS (n = 37), those in the LGG group were more likely to have treatment success than those in the placebo group (33% vs. 5%, RB 6.3, 95% CI: 1.2-38, NNT 4, 95% CI: 2-36) and reduced frequency of pain (P = 0.02), but not pain severity (P = 0.10). For the FD group (n = 20) and FAP group (n = 47), no differences were found. CONCLUSION The LGG appears to moderately increase treatment success, particularly among children with IBS.