Efficacy of a partially hydrolyzed whey formula on infant colic: a randomized controlled trial

Background: Infant colic (IC) affects up to 20% of infants in the first 4 months of life. Although IC is a benign affection that spontaneously resolves after the first 3-4 months of life, it is often a stressful problem for parents. Methods: Babies, aged ≤ 3 months, observed at family pediatrician office because a suspect of IC, were randomized in two groups of 3-week dietary intervention: Group 1, receiving non-analgesic, non-nutritive soothing maneuvers, continuing a standard formula; Group 2, receiving a partially hydrolyzed whey formula (w-pHF), containing GOS (0.5g/100ml), low content of lactose (2.5g/100ml) and low osmolarity (185 mOsm). All infants performed clinical examinations at enrollment and after 7, 14 and 21 days. Number of colic episodes, and the number and consistency of fecal outputs were recorded daily. Results: Fifty infants with IC were enrolled and randomized: 25 in Group 1 and 25 in Group 2. The rate of infants with IC in Group 2 decreased significantly within 14 days compared to Group 1 and the number of bowel movements increased significantly within 7 days in Group 2 compared to Group 1. Stool consistency significantly improved in Group 2 within 7 days. Conclusion: The studied formula could represent a useful approach in infants with IC reducing pharmacological treatments.