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OBJECTIVE:The Cow's Milk-related Symptom Score (CoMiSSTM) was developed as an awareness tool to recognize possible manifestations of cow's milk protein allergy (CMPA). Arbitrarily, a cut-off value of ≥12 was defined as a "positive score." The aim of this study was to determine an age-related CoMiSS in healthy infants to minimize the risk of false reassurance or over-diagnosis of CMPA in case of a negative or positive score, respectively. METHODS:General pediatricians determined the CoMiSS in presumed healthy infants aged ≤6 months during a routine visit. Exclusion criteria included any known acute or chronic disease, preterm delivery (< 37 weeks), therapeutic formula, any food supplement (except vitamins) or medication. RESULTS:Data from 891 consecutive infants were collected. Complete information was obtained from only 413 (46.4%) infants: Belgium: 31.2%, Italy 18.2%, Poland 19.1% and Spain 31.5%. Since gender (girls vs boys) (p = 0.579) had no influence on the CoMiSS, the data were re-calculated to include those infants with missing gender. The overall median and mean (SD) CoMiSS scores were, respectively, 3.0 and 3.7 (2.9). The 95th percentile was 9. Median crying (p<0.001), regurgitation (p = 0.009) and eczema (p = 0.039) scores differed significantly across the age categories. The other components of the CoMiSS were not age dependent. CONCLUSION:In healthy infants ≤ 6 months, the median CoMiSS is 3.0. More prospective studies in different sites and comparing healthy and allergic infants are warranted to obtain further evidence on the utility of the CoMiSS.