The aim of this study was to investigate the role of Lactobacillus reuteri DSM 17983 in the treatment of functional constipation in children. The trial was a single-center randomized, double-blind, placebo-controlled study. Patients were allocated into the 2 groups; intervention group which received L reuteri DSM 17983 and lactulose and placebo group which received placebo and lactulose. Due to small recruitment rate study was terminated prematurely; therefore, only 33 children (12 girls, median age 4.5 years, range 2-16) were randomized. There was no difference between groups in the stool frequency, stool consistency, pain, soiling rate and dose of the lactulose. This study found that L reuteri DSM 17938 adds no benefit to the treatment of constipation in children. Due to small sample size, these results, however, should be interpreted with caution.
Trial registration: ClinicalTrials.gov NCT01587846.