Lactobacillus reuteri DSM 17938 is effective in the treatment of functional abdominal pain in children: Results of the double-blind randomized study.

BACKGROUND & AIMS: Possible therapeutic effect of Lactobacillus (L.) reuteri DSM 17938 has been reported in children with functional abdominal pain (FAP) but data are inconclusive. METHODS: This is a randomized double-blinded controlled trial (RCT) which assessed effect of L. reuteri DSM 17938 (dose 108 CFU/day) in children (age 4-18 years) on FAP during an intervention period of 12 weeks and follow-up of 4 weeks. This study was performed after the interim analysis and had different labeling of products and a new randomization. Data presented here are results of this RCT and pooled data from both RCTs (before and after interim analysis). RESULTS: This RCT included 46 children (median age 10.1 vs 10.6 years; 11 vs 13 girls). Abdominal pain was less severe in intervention group during the 4th month of the study and there was significant increase in the number of days without pain. Pooled data from both parts of the study included 101 children. Number of days without pain was significantly higher in the L. reuteri group (mean difference 26.42 days, 95% CI 22.47-30.17). Significant difference in the pain intensity was found after 2nd, 3rd and 4th month of the intervention. There was no difference between groups in the number of children in whom symptoms completely ceased (Risk Ratio 1.09, 95% CI 0.75-1.58). CONCLUSION: Administration of L. reuteri DSM 17938 was associated with the reduction in the intensity of pain and with significantly increase in pain-free days in children with FAP.