This randomized, doubleblind study was performed on 50 breastfed infants who were
consecutively recruited from children medical center. All infants were diagnosed with infantile colic according Wessel’s criteria: episodes of fussy crying lasted _3 hours a day and episodes _3 days in the 1 week before enrollment. Exclusion criteria were clinical evidence of chronic illness or gastrointestina disorders, intake of probiotics and/or antibiotics in the week preceding recruitment, and formula-feeding. Befor the start, and written informed consent was obtained from parents before inclusion of the infants. Colicky infants were randomly assigned to receive BioGaia drop or placebo. The bottles were coded and blinded by the study statistician for both the participants and for the physicians, and the code was revealed to the investigators once recruitment, data collection and all laboratory and statistical
analyses were complete. At enrollment (day 0), parents were interviewed about gestational age, type
of delivery, birth weight, presence of gastrointestinal disease, and crying time. Medical examinations were performed, and growth parameters were recorded at baseline and day 21. Parents were asked to fill in a structured diary to record the daily crying time (minutes), stool characteristics and frequency, and any adverse effects observed
on each day of the study. A general linear model for repeated measures was used to assess differences in growth parameters between groups at the different time points (day 0 –21).
Follow-up visits were performed by the same pediatrician on day 7 and 14 and 21.