Symptoms of crying and discomfort from infantile colic have plagued both parents and physicians for years. Few therapeutic options exist. The etiology is most likely multifactorial, but some evidence favors motility dysfunction. We initiated a randomized, double-blind, placebo -controlled, crossover study to test the hypothesis that cisapride (0.2 mg/kg QID) would reduce the symptom of crying associated with colic. Healthy, normally growing infants, without symptoms of constipation or GER, and not concurrently treated for colic(medications or elemental formulas) and who fit the classic definition of colic, were enrolled. During the study period, the parents kept crying time logs which have previously been shown to have good correlation to actual crying times (r=0.85-0.9). After a 3 day observation period, the patients received 6 days of either placebo or cisapride which was then crossed over after a 2 day washout period. The parents subjectively rated each week for efficacy of the medication/placebo. At this time, twenty-six patients have completed this ongoing study. Some patients have appeared to show a dramatic response to treatment of colic with cisapride. Results of initial statistical analysis failed to show significant differences in crying times between cisapride (0.87±1.49,mean±SD) and placebo (0.36±1.33) or parental subjective rating. A trend to decreased hours of crying on cisapride over placebo is present, but large standard deviations in crying times between infants exist. A larger sample size may allow demonstration of statistically significant differences in crying times.

Conclusion: Cisapride may prove to be beneficial in the treatment of colic; however, sample size of the present study does not allow conclusive evidence of its value.