Efficacy of a partially hydrolysed formula, with reduced lactose content and with Lactobacillus reuteri DSM 17938 in infant colic: A double blind, randomised clinical trial

Background & aims: We aimed to compare the efficacy of a partially hydrolysed formula (pHF) with reduced lactose content and Lactobacillus reuteri DSM 17938 (L. reuteri) with a standard formula in infant colic (IC). Methods: We performed a double blind, parallel-group randomized active-controlled. Inclusion criteria were: exclusively formula fed, full term infants, aged <4 months, diagnosis of IC. All the enrolled infants were randomized to receive either pHF with reduced lactose content and L. reuteri (Group A) or standard formula (Group B). The treatment duration was 4 weeks and children were followed-up to 8 weeks. The primary outcome was the mean infant crying duration at 28 days. Results: Two-hundred-forty-one children were randomized to the treatments’ group (Group A = 124; Group B = 117). Mean daily crying time at 28th day was significantly lower in Group B when compared to Group A [104.7 (87–122.4) versus 146.4 min (129.2–163.7), treatment effect −41.8 (95% C.I.: −66.5 to −17.1), p = 0.001]. No significant adverse event was reported in both groups. Conclusions: Standard formula showed a lower overall crying time respect to the intervention formula (ClinicalTrials.gov NCT02813772).