Lactobacillus reuteri (DSM 17938) in infants with functional chronic constipation: a double-blind, randomized, placebo-controlled study.

OBJECTIVES: To evaluate the beneficial effects of Lactobacillus reuteri (DSM 17938) in infants with functional chronic constipation. STUDY DESIGN: A double-blind, placebo-controlled, randomized study was conducted from January 2008 to December 2008 in 44 consecutive infants at least 6 months old (mean age+/-SD, 8.2+/-2.4 SD; male/female, 24/20) admitted to the Gastrointestinal Endoscopy and Motility Unit of the Department of Pediatrics, University "Federico II" of Naples, with a diagnosis of functional chronic constipation. The 44 infants with chronic constipation were randomly assigned to 2 groups: group A (n=22) received supplementation with the probiotic L reuteri (DSM 17938) and group B (n=22) received an identical placebo. Primary outcome measures were frequency of bowel movements per week, stool consistency, and presence of inconsolable crying episodes, recorded in a daily diary by parents. RESULTS: Infants receiving L reuteri (DSM 17938) had a significantly higher frequency of bowel movements than infants receiving a placebo at week 2 (P=.042), week 4 (P=.008), and week 8 (P=.027) of supplementation. In the L reuteri group, the stool consistency was reported as hard in 19 infants (86.4%) at baseline, in 11 infants (50%) at week 2, and in 4 infants (18.2%) at weeks 4 and 8. However, there was no significant difference between L reuteri and placebo groups in the stool consistency at all weeks (P=.63, week 2; P=.38, week 4; P=.48, week 8). Similarly, there was no statistically difference in the 2 groups in the presence of inconsolable crying episodes. No adverse effects were reported. CONCLUSIONS: The administration of L reuteri (DSM 17938) in infants with chronic constipation had a positive effect on bowel frequency, even when there was no improvement in stool consistency and episodes of inconsolable crying episodes. Because of their safety profile, probiotics may be an attractive option in the treatment of functional constipation.