To determine the relative risk of developing atopic dermatitis in infants fed a study formula based on whole goat milk compared to infants a study formula based on cow milk protein.
The study is a randomized, double-blind, parallel-group trial to study the effect of feeding infants goat milk or cow milk formula in the first year of life on the risk of allergy and other health outcomes, including growth, tolerance and quality of life in the first 5 years of life.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
2,132
Infant formula and follow-on formula made from whole goat milk
Infant formula and follow-on formula made from cow's milk ingredients
Dr. von Hauner Children's Hospital, LMU University Hospital Munich
Munich, Germany
Wojewodzki Specjalistyczny Szpital Dzieciecy
Olsztyn, Poland
Karol Jonscher's University Hospital
Poznan, Poland
Cumulative incidence of atopic dermatitis up to the age of 12 months
Cumulative incidence of atopic dermatitis up to the age of 12 months diagnosed by study personnel (defined as meeting the UK Working Party Diagnostic Criteria for atopic dermatitis)
Time frame: Age 12 months
Cumulative incidence of atopic dermatitis up to the age of 24 and 60 months
Cumulative incidence of atopic dermatitis up to the age of 24 and 60 months diagnosed by study personnel (defined as meeting the UK Working Party Diagnostic Criteria for atopic dermatitis)
Time frame: Age 24 and 60 months
Cumulative incidence of parental reported diagnosis of atopic dermatitis up to the age of 12, 24 and 60 months
Cumulative incidence of parental reported diagnosis of atopic dermatitis up to the age of 12, 24 and 60 months, defined as meeting the UK Working Party Diagnostic Criteria for atopic dermatitis
Time frame: Age 12, 24 and 60 months
Point incidence of atopic dermatitis
Point incidence of study and parental diagnosis of atopic dermatitis, defined as meeting the UK Working Party Diagnostic Criteria for atopic dermatitis at the age of 4, 6, 12, 24 and 60 months
Time frame: at 4, 6, 12, 24 and 60 months of age
Time to onset of atopic dermatitis
Age at first study or reported diagnosis of atopic dermatitis up to the age of 12, 24 and 60 months
Time frame: Age 12, 24 and 60 months
Severity of atopic dermatitis
Atopic dermatitis severity in children with diagnosed (study diagnosis or reported diagnosis) atopic dermatitis, using the SCORing Atopic Dermatitis (SCORAD; Severity Score: 0 to 104, with a higher score indicating more severe eczema) questionnaire completed by a study nurse at all face-to-face visits at 4, 6, 12, 24 and 60 months of age.
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Medical College of Rzeszow University
Rzeszów, Poland
Children's Memorial Health Institute
Warsaw, Poland
Unit of Pediatric Gastroenterology and Nutrition, Torrecardenas University Hospital
Almería, Spain
EURISTIKOS Excellence Centre for Paediatric Research, University of Granada
Granada, Spain
Department of Neonatology, Hospital Universitario La Paz
Madrid, Spain
Hospital Universitari Sant Joan de Reus
Reus, Spain
Hospital Universitari Joan XXIII de Tarragona
Tarragona, Spain
...and 2 more locations
Time frame: at 4, 6, 12, 24 and 60 months of age
Severity of atopic dermatitis
Atopic dermatitis severity in children with diagnosed (study diagnosis or reported diagnosis) atopic dermatitis, using the Patient Orientated Eczema Measure (POEM; Severity Score: 0 to 28, with a higher score indicating more severe eczema) questionnaire completed by parents at 4, 6, 8, 10, 12, 18, 24, 36, 48 and 60 months of age
Time frame: at 4, 6, 8, 10, 12, 18, 24, 36, 48 and 60 months of age
Cumulative use of atopic dermatitis-related medication
Cumulative use of eczema-related medication or skin care for eczema up to 12, 24 and 60 months of age
Time frame: Age 12, 24 and 60 months of age
Cumulative incidence of atopic dermatitis in risk-related subgroups
Cumulative incidence of atopic dermatitis in risk-related subgroups up to 12, 24 and 60 months of age
Time frame: Age 12, 24 and 60 months of age
Incidence of parental reported food allergy
Parental report of a clinical diagnosis of food allergy at 12, 24 and 60 months of age
Time frame: Age 12, 24 and 60 months of age
Incidence of allergic sensitization to food or non-food allergens
Allergic sensitization at 12 and 60 months of age to any of the common allergens (specific and total IgE)
Time frame: Age 12 and 60 months of age
Incidence of hay fever, asthma and asthma-related diseases
Parental reported hay fever and asthma-related diseases (wheezing and allergic rhinitis) up to 12, 24 and 60 months of age
Time frame: Age 12, 24 and 60 months
Biochemical markers: blood markers
Blood: complete blood count (given numbers of different cells per volume and suitable ratios) at 4, 12 and 60 months of age
Time frame: at 4, 12 and 60 months of age
Biochemical and metabolic markers: blood markers
Blood: lipidome and metabolome (including more than 300 compounds reported in µmol/liter) at 4, 12 and 60 months of age
Time frame: at 4, 12 and 60 months of age
Biochemical and metabolic markers: blood markers
Blood: inflammation markers (including immunoglobulins and cytokines reported as relative units/liter and ng/ml, respectively) at 4, 12 and 60 months of age
Time frame: at 4, 12 and 60 months of age
Genetic markers: blood markers
Blood: filaggrin gene at 12 months of age
Time frame: at 12 months of age
Gut microbiome profile
Stool: microbiome
Time frame: at 4, 12 and 60 months of age
Growth parameters
Anthropometry: weight (in kg) at baseline, 4, 6, 12, 24 and 60 months of age
Time frame: at baseline, 4, 6, 12, 24 and 60 months of age
Growth parameters
Anthropometry: recumbent length (in cm) at baseline, 4, 6, 12, 24 and standard height (in cm) at 24 and 60 months of age
Time frame: at baseline, 4, 6, 12, 24 and 60 months of age
Growth parameters
Anthropometry: BMI (weight and height will be combined to report BMI in kg/cm2) at baseline, 4, 6, 12, 24 and 60 months of age
Time frame: at baseline, 4, 6, 12, 24 and 60 months of age
Growth parameters
Anthropometry: weight-for-age, length-for-age and BMI-for-age z-scores (WHO growth standards) at baseline, 4, 6, 12, 24 and 60 months of age
Time frame: at baseline, 4, 6, 12, 24 and 60 months of age
Gastrointestinal symptoms
Parental report of gastrointestinal symptoms using the Infant Gastrointestinal Symptom Questionnaire (IGSQ; Index Score range from 13 to 65, with higher scores indicating greater gastrointestinal symptom burden) at 4, 6 and 12 months of age
Time frame: at 4, 6 and 12 months of age
Sleep
Parental report of sleep using the Brief Infant Sleep Questionnaire (BISQ; data in time: hours and minutes of sleep time) at 4, 6 and 12 months of age
Time frame: at 4, 6 and 12 months of age
Child's wellbeing
Parental report of quality of life in children using the Infant Toddler Quality of Life questionnaire™ (ITQOL; infant and parent item scales range from 0 to 100, with a higher score indicating better health) at 4, 12, 24 and 60 months of age
Time frame: at 4, 12, 24 and 60 months of age
Nutrition
Nutrition questionnaire at 4, 6, 8, 10, 12 and 60 months of age
Time frame: at age 4, 6, 8, 10, 12 and 60 months of age