K. Chau,1 E. Lau,2 S. Greenberg,2 S. Jacobson,2 P. Yazdani-Brojeni,2 N. Verma,2 G. Koren2; 1University of Toronto, Toronto, ON, Canada, 2The Hospital for Sick Children, Toronto, ON, Canada
BACKGROUND: Evidence exists demonstrating an association between the intestinal microbiota and infantile colic. The aim of this study was to determine whether supplementation Lactobacillus reuteri DSM 17938 improves infantile colic symptoms compared to placebo.
METHODS: This randomized double-blind placebo controlled study recruited 52 colicky infants (crying and/or fussing for ≥3 hrs/d on ≥3 d/wk for 7 d) and randomly assigned infants to receive placebo or L. reuteri at a standard dose of 108 colony-forming units once daily for 21 days. Daily crying and/or fussing times were recorded on a maternal diary; changes in colic episodes and adverse events were collected on days 7, 14 and 21.
RESULTS: Total average crying and fussing time (minutes) from baseline to day 21 were significantly shorter among colicky infants in the probiotic group compared to the placebo group: 1719±750 min (29±13 hr) and 2195±764 min (37±13 hr) (P=0.028), respectively [relative risk (RR) 0.78(95% confidence interval (CI) 0.58-0.98)]. Infants administered L. reuteri DSM 17938 showed a significant reduction in daily crying and fussing time (minutes/day) compared to those receiving placebo (median [IQR]): 60 (64) and 102 (87), (P=0.045), respectively. On Day 21, a significantly higher proportion of infants in the L. reuteri DSM 17938 group responded to treatment by more than 50% crying time reduction compared to infants administered placebo: 17 vs. 6 (P=0.035) [RR 3.3(95% CI 1.55-7.03)].
CONCLUSION: The results from this study confirm that supplementation with L. reuteri DSM 17938 significantly reduces crying and fussing times in breastfed colicky infants compared to placebo. Furthermore, this study demonstrates the excellent safety profile of L. reuteri DSM 17938 and deems it an effective treatment for infantile colic.