Summary: Background: The prevalence of infant colic is high and it has a significant impact on the live of the infants and their families, given that effective treatment has not been found. Objective: The aim of this study to evaluate the effects of pedilact probiotic drops for the treatment of infants colic in children. Methods: This study was carried out on 72 infants, presented with infantile colic who were admitted to the Tehran children Medical Center. These children were assigned randomly (using 2 blinded-randomized trial) into two equal groups named PRR (Probiotic receiving) and PCR (Placebo receiving) groups. The demographic information of the infants such as age and sex, maternal age, patient admission time and confounding factors such as passive smoker, family history of atopy, antibiotic use, and delivery type was recorded in both groups based on the statements provided by the mothers. The weight of the infants was also recorded. Results: There was no significant difference in the distribution of infant's sex, mother's age, type of labor, type of nutrition, quality of life and exposure to smoke between the two groups. The weight of the newborns increased in each of the two groups and there was a significant increase in the PRR group (p value < 0.0001), while in the PCR group no significant growth was observed (p value = 0.437). The frequency of crying in both groups decreased over the time, which was significant in PRR group only (p value < 0.001). There were no significant difference between PRR and PCR groups in fecal consistency and pattern of sleep on each day of 0, 7, 14, 21, and 28 (28 days p value = 0.475 and 0.086, respectively). Conclusion: Probiotic therapy significantly reduced the frequency and duration of crying and increased neonatal weight gain during the study, which can chiefly improve the quality of life.
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