Treating the infant colic syndrome by counseling the parents concerning more effective responses to the infant crying is compared to the elimination of soy or cow's milk protein from the infant's diet in a randomized clinical trial. Because symptoms of vomiting and diarrhea are not part of the infant colic syndrome, infants with these gastrointestinal symptoms were excluded from the study. Dietary changes were accomplished by either feeding the infants a hydrolyzed casein formula or by requiring mothers to eliminate milk from their diets. In phase 1 of the study, the group receiving counseling (n = 10) had a decrease in crying from 3.21 ± 1.10 h/d to 1.08 ± 0.70 h/d (P = .001). The crying in the group that received dietary changes (n = 10) decreased from 3.19 ± 0.69 h/d to 2.03 ± 1.07 h/d (P = .01), a level still greater than twice normal. The decrease in those receiving counseling was faster and greater than that of those given dietary changes (P < .02). In the second phase of the study, group 2 infants were reexposed to cow's milk or soy protein and the parents received counseling. In this phase, counseling again decreased crying significantly from 2.09 ± 1.07 h/d to 1.19 ± 0.60 h/d (P = .05). No infant in the study who improved with changes in his or her diet had a significant increase in crying, with reexposure to soy or cow's milk protein. It is concluded that these data support the theory that for many infants with the infant colic syndrome the crying is a result of parental misinterpretation of infant cries and is not caused by milk protein allergy.

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