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| Name | Class |
|---|---|
| Klinikum der Universität München | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental formula | Experimental | Infant and follow-on goat milk formula |
|
| Control formula | Active Comparator | Infant and follow-on cow milk formula |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Infant formula and follow-on formula made from whole goat milk | Dietary Supplement | Infant formula and follow-on formula made from whole goat milk |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Age 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Age 24 and 60 months |
| Cumulative incidence of parental reported diagnosis of atopic dermatitis up to the age of 12, 24 and 60 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Berthold Koletzko, MD, PhD | Dr. von Hauner Children's Hospital, LMU University Hospital Munich | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dr. von Hauner Children's Hospital, LMU University Hospital Munich | Munich | Germany | ||||
| Wojewodzki Specjalistyczny Szpital Dzieciecy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42275985 | Derived | Grote V, Schlosser L, Campoy C, Crehua-Gaudiza E, Demmelmair H, Ege MJ, Escribano J, Galera-Martinez R, Garcia-Santos JA, Gruszfeld D, Guerlich K, Guillen-Sebastian C, Handel U, Jamka M, Jarocka-Cyrta E, Ksiazyk J, Mazur A, Parada-Ricart E, Robredo-Garcia I, Rodriguez G, Romanczuk B, Saenz de Pipaon M, Tejon-Fernandez M, Walkowiak J, Weichselbaum E, Witte A, Koletzko B. Whole goat milk versus cow milk formula and atopic dermatitis in infants: A randomized clinical trial. Clin Nutr. 2026 Jun 3;63:106707. doi: 10.1016/j.clnu.2026.106707. Online ahead of print. | |
| 37055203 |
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Parallel assignment
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Quadrupole
| Infant formula and follow-on formula made from cow's milk ingredients | Dietary Supplement | Infant formula and follow-on formula made from cow's milk ingredients |
|
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 |
| 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 | 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 | 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. | 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 | 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 | 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 | 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 | 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) | 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 | 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 | 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 | 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 | at 4, 12 and 60 months of age |
| Genetic markers: blood markers | Blood: filaggrin gene at 12 months of age | at 12 months of age |
| Gut microbiome profile | Stool: microbiome | 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 | 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 | 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 | 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 | 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 | 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 | 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 | at 4, 12, 24 and 60 months of age |
| Nutrition | Nutrition questionnaire at 4, 6, 8, 10, 12 and 60 months of age | at age 4, 6, 8, 10, 12 and 60 months of age |
| Olsztyn |
| Poland |
| Karol Jonscher's University Hospital | Poznan | Poland |
| 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 |
| INCLIVA Health Research Institute | Valencia | Spain |
| Hospital Clinico Universitario Lozano Blesa, Instituto de investigacion Sanitaria de Aragon | Zaragoza | Spain |
| Derived |
| Ferry JM, Galera-Martinez R, Campoy C, Saenz de Pipaon M, Jarocka-Cyrta E, Walkowiak J, Romanczuk B, Escribano J, Gispert M, Grattarola P, Gruszfeld D, Iglesia I, Grote V, Demmelmair H, Handel U, Gallier S, Koletzko B. Effects of infant feeding with goat milk formula or cow milk formula on atopic dermatitis: protocol of the randomised controlled Goat Infant Formula Feeding and Eczema (GIraFFE) trial. BMJ Open. 2023 Apr 13;13(4):e070533. doi: 10.1136/bmjopen-2022-070533. |
| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D041943 | Infant Formula |
| ID | Term |
|---|---|
| D041941 | Milk Substitutes |
| D001628 | Beverages |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D005526 | Food, Formulated |
| D019648 | Foods, Specialized |
| D005502 | Food |
| D007225 | Infant Food |
| D019602 | Food and Beverages |
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