Lactobacillus reuteri DSM 17938 for the management of infantile colic in breastfed infants: a randomized, double-blind, placebo-controlled trial.

OBJECTIVE To determine whether administration of Lactobacillus reuteri (L reuteri) DSM 17938 is beneficial in breastfed infants with infantile colic. STUDY DESIGN Eighty infants aged <5 months with infantile colic (defined as crying episodes lasting 3 or more hours per day and occurring at least 3 days per week within 7 days prior to enrollment), who were exclusively or predominantly (>50%) breastfed were randomly assigned to receive L reuteri DSM 17938 (10(8) colony-forming units) (n = 40) or an identically appearing and tasting placebo (n = 40), both orally, in 5 drops, 1 time daily, for 21 days. The primary outcome measures were the treatment success, defined as the percentage of children achieving a reduction in the daily average crying time ≥ 50%, and the duration of crying (minutes per day) at 7, 14, 21, and 28 days after randomization. RESULTS The rate of responders to treatment was significantly higher in the probiotic group compared with the placebo group at day 7 (P = .026), at day 14 (relative risk (RR) 4.3, 95% CI 2.3-8.7), at day 21 (RR 2.7, 95% CI 1.85-4.1), and at day 28 (RR 2.5, 95% CI 1.8-3.75). In addition, throughout the study period, the median crying time was significantly reduced in the probiotic group compared with the control group. CONCLUSION Exclusively or predominantly breastfed infants with infantile colic benefit from the administration of L reuteri DSM 17938 compared with placebo.