Efficacy and safety of a probiotic-mixture for the treatment of infantile colic: A double blind, randomized, placebo-controlled clinical trial

Objective: Infantile colic is a frequent problem in neonates and infants. Aim of this study was to investigate the effectiveness and the safety of a probiotic-mixture for the treatment of infantile colic in breastfed infants, compared with placebo. Methods: A randomized, double blind, placebo-controlled trial was conducted in exclusively breastfed infants with colic, randomly assigned to receive a probiotic-mixture or placebo for 21 days. A diary on gastrointestinal events in newborns was given to parents. Diaries, family quality of life, infants’ anthropometrics data and adverse events were monitored weekly. Results: 53 exclusively breastfed infants completed the three weeks of probiotic-mixture (n. 27) or placebo (n. 26) treatment. Probiotic-Mixture Group (PMG) showed a reduction in average minutes of crying per day throughout the study and reached statistical significance at the end of treatment period, compared with those receiving placebo (PG) (68.4 vs 98.7; p = 0.001). A higher rate of infants in PMG responded to treatment compared with the PG at day 14, 12 vs 5 (p = 0.04); and at day 21, 26 vs 17 (p = 0.00). A higher quality of life was reported by parents of PMG compared with those of PG at day 14, 7.1 ± 1.2 vs 7.7 ± 0.9 (p = 0.02); and at day 21, 6.7 ± 1.6 vs 5.9 ± 1.0 (p = 0.00). No differences between groups are collected regarding infants’ anthropometric data, number of bowel movements and stool consistency. No adverse events were reported related to the study intervention. Conclusions: Administration of a probiotic-mixture for the treatment of infantile colic reduces the minutes of inconsolable crying per day in exclusively breastfed infants.