1 Department of Pediatrics, Arak University of Medical Sciences, Arak, Iran.

2 Medical Ethics and Law Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.

3 Department of Epidemiology and Reproductive Health, Reproductive Epidemiology Research Center, Royan Institute for Reproductive Biomedicine, ACECR, Tehran, Iran.


Background: Infantile colic imposes a heavy financial burden on families and the healthcare system. This study was conducted to evaluate the effect of Pedilact on the treatment of infantile colic.
Materials and Methods: In this randomized clinical trial, 84 infant younger than 3 months with infantile colic were divided in two groups of 42 cases each- probiotic and standard treatment. This study was done in Arak city, Iran between 2013 and 2016. The population of the study consisted of breastfed infants and formula-fed infants younger than 3 months (less than 13 weeks) who referred to Amir Kabir Hospital and pediatric clinics presenting crying and restlessness symptoms consistent with the modified Wessel criteria. In the treatment group, in addition to the main treatment, five drops of Pedilact (Iran) was daily administered for 28 days. In both groups, the main treatment was instructed to the parents and they were advised to do the following techniques to pacify the infant: making relaxing sounds or vocals, applying peaceful and rhythmic rocking motion, walking, and using mild tremor-like movements.
Results: In Pedilact and control groups, 54.75% and 28.57% of the cases were male, respectively. 23 infants (75.61%) in the Pedilact group and 33 infants (82.5%) in the control group were breastfed infants. The mean age of infants in Pedilact and control groups were 6.64 + 2.90 and 6.69 + 5.97, respectively.There was no significant difference between the Pedilact and control groups in terms of mean duration of crying time during a day (P= 0.075), and the number of crying attacks per day (P= 0.127), there was a significant decrease in both variables over time, but the mean for hours of sleep in the group receiving the standard treatment was significantly higher than that of the group receiving Pedilact (P= 0.001).
Conclusion: There was no significant difference between the control and Pedilact groups in terms of crying time during a day and the number of crying attacks. It should be mentioned that, in this study, sample size was relatively low; hence, a multicenter study is recommended.