The effect of symbiotic in the treatment of infantile colic: A double-blind, randomized, placebo-controlled clinical trial

BACKGROUND: This study aims to evaluate the effect of symbiotic (Pedilact) on the treatment of infantile colic. MATERIALS AND METHODS: In this randomized clinical trial in Zanjan, Iran, 76 infants with infantile colic were assigned to two groups of 38 cases using block randomization. The intervention group received 5 drops of Pedilact, a symbiotic containing Lactobacillus reuteri and simethicone (20 mg twice daily), and the control group received placebo in addition to simethicone for 4 weeks. Daily crying time, number of crying attacks per day, and sleep duration were recorded on days 1, 7, 14, 21, and 28, and the results were compared. RESULTS: Thirty-three infants in the intervention group and 35 infants in the control group were enrolled. There was no significant difference between the two groups in terms of age, gender, gestational age, maternal age, type of delivery, type of feeding, and weight at the beginning and the end of the study (all P > 0.05). Daily crying time in the control and intervention groups decreased from 240 and 210 min/day, respectively, to 0 min/day in both the groups. Daily crying attacks decreased from 5 and 4/day in the control and intervention groups, respectively, to 0/day. Sleep duration in both the groups increased from 720 to 840 and 930 min/day in the control and intervention groups, respectively, but the changes were not significant (P = 0.56, P = 0.52, and P = 0.13, respectively). CONCLUSION: We did not find a significant improvement in colic symptoms in infants receiving symbiotic compared to placebo.