The Cow's Milk-related Symptom Score (CoMiSS) is an awareness tool for evaluating cow's milk-related symptoms. Previous studies have focused on providing CoMiSS values for healthy and symptomatic infants aged 0-6 months. However, there is a notable gap in the literature concerning CoMiSS values for infants older than 6 months. This cross-sectional study aimed to determine CoMiSS values in presumed healthy infants who have completed 6 months and are up to 12 months old, hereafter referred to as 6 to 12 months old. Physicians from six European countries prospectively determined CoMiSS values in infants attending well-child clinics. Exclusion criteria included preterm delivery, acute or chronic disease, and the consumption of a therapeutic formula, dietary supplements (except vitamins), or medication. The following information was collected: gestational age, gender, age, type of feed (breast milk or infant formula), and complementary feeding. Descriptive statistics were summarized with mean and standard deviation for normally distributed continuous variables, median and IQR for non-normally distributed variables, and differences in CoMiSS values were analyzed with appropriate tests. Data from 609 infants were obtained. The overall median (Q1-Q3) CoMiSS values were 3 (1-5). Significant differences were found across age groups (p < 0.001), but not across groups based on gender (p = 0.551) or feeding type (p = 0.880). Conclusions: This study provided CoMiSS values in presumed healthy infants aged 6-12 months. Additional studies should be conducted to establish the use of CoMiSS to assess cow's milk-related symptoms in infants 6 months and older. What is Known: • The Cow's Milk-related Symptom Score (CoMiSS) is an awareness tool for evaluating symptoms related to cow's milk. • CoMiSS values for presumed healthy infants aged 0-6 months infants are already available. What is New: • CoMiSS values in European infants aged 6-12 months are provided. • These CoMiSS values differed across various age groups but not across groups based on gender or feeding type.

Children's Hospital University of Helsinki and Helsinki University Hospital Helsinki Finland

Department Dietetics Winchester University Winchester SO23 4NR UK

Department Medicine KU Leuven Louvain Belgium

Department of Hygiene and Epidemiology Faculty of Public Health Medical University of Varna Varna Bulgaria

Department of Internal Medicine Geriatrics and Practical Medicine University Hospital Brno and Masaryk´S University Brno Czech Republic

Department of Paediatrics The Medical University of Warsaw Żwirki 1 Wigury 63A 02 091 Warsaw Poland

Department of Paediatrics University of Insubria Varese Italy

Department of Pediatrics University Hospital Brno and Masaryk's University Brno Czech Republic

Department of Translational Medical Science Section of Pediatrics University Federico 2 Naples Italy

Department Paediatrics Imperial College London London SW7 2BX UK

Hospital La Salud Universidad Católica de Valencia San Vicente Mártir Valencia Spain

Institute of Gastroenterology Nutrition and Liver Diseases Schneider Children's Medical Center Lea and Arieh Pickel for Pediatric Research Faculty of Medicine Tel Aviv University Tel Aviv Israel

Pediatric Gastroenterology La Fe University Hospital Instituto de Investigation Sanitaria La FE Valencia Valencia Spain

Ramsay Group France Et Clinique Marcel Sembat Paris Descartes University Boulogne Billancourt Paris France

Research Group NutriLect Department of Neuroscience Research Institute Medical University Prof Dr Paraskev Stoyanov Varna Bulgaria

Vrije Universiteit Brussel UZ Brussels KidZ Health Castle Laarbeeklaan 101 Brussels Belgium

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The evolution of Cow's Milk-related Symptom Score (CoMiSS™) in presumed healthy infants