Infantile colic: Crying time reduction with a whey hydrolysate: A double-blind, randomized, placebo-controlled trial

Objective. To determine the effectiveness of whey hydrolysate formula in the treatment of infantile colic in a primary care setting in the Netherlands. Study Design. Randomized, double-blind, parallel trial with a 1-week qualification period and a 1-week intervention period. Participants. Forty-three healthy, thriving, formula-fed infants, <6 months old, crying >3 hours per day on at least 3 days per week. Infants were randomized to whey hydrolysate formula (n = 23) or standard formula (n = 20). Main Outcome Measure. Difference in duration of crying (minutes per day) between qualification week and intervention week. Results. Analysis according to the intention to treat principle showed a difference in the decrease of crying duration of 63 minutes per day [95% confidence interval: 1-127 minutes per day] in favor of the whey hydrolysate formula. Five infants did not complete the trial. The scope of the study was not sufficient to expect significant differences in the subgroup analyses. Conclusions. An extensively hydrolyzed whey formula is effective in reducing the duration of crying in a primary care setting.