Goat Infant Formula Feeding and Eczema (the GIraFFE Study)

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Effects of Infant Feeding With Goat Milk Formula or Cow Milk Formula on Atopic Dermatitis

Conditions
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Dermatitis, Atopic, Eczema, Infantile, Infant Development, Child Development

Intervention / Treatment
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* Dietary Supplement: Infant formula and follow-on formula made from whole goat milk
* Dietary Supplement: Infant formula and follow-on formula made from cow's milk ingredients


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Having obtained written informed consent (signed and dated) of the child's parent(s)/caregiver(s), indicating that the child's parent(s)/caregiver(s) has/have been informed of all pertinent aspects of the study Born full term (≥37 weeks +0 days and ≤ 41 weeks +6 days of gestation) Age at enrolment < 3 months of age (<90 days) Birth weight ≥2.5 kg and ≤4.5 kg Born from a singleton pregnancy Child's parent(s)/caregiver(s) is/are of legal age of consent The child's parent(s)/caregiver(s) have sufficient local language skills to understand the study information, the informed consent, and to comply with the study procedure The child's parent(s)/caregiver(s) is/are willing and deemed able to fulfil the requirements of the study protocol and procedures Mother has expressed the intention to partially (in combination with breastfeeding) or fully formula-feed Exclusion Criteria: Diagnosed disorder considered to interfere with nutrition, growth or development of the immune system Participation of the child in any other interventional trial or participation of the mother in any intervention trial with child follow-up Infant has a doctor's diagnosis of atopic dermatitis or a severe widespread skin condition prior to randomization that would make the detection or assessment of atopic dermatitis difficult Infant has consumed an infant formula for more than 4 weeks prior to enrolment Cow milk allergy or intolerance Institutionalized infant

Ages Eligible for Study
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Minimum Age: 0 Days
Maximum Age: 90 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Parallel assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental formula<br>Infant and follow-on goat milk formula | Dietary Supplement: Infant formula and follow-on formula made from whole goat milk<br>* Infant formula and follow-on formula made from whole goat milk<br>|
| Active Comparator: Control formula<br>Infant and follow-on cow milk formula | Dietary Supplement: Infant formula and follow-on formula made from cow's milk ingredients<br>* Infant formula and follow-on formula made from cow's milk ingredients<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Atopic Dermatitis, Healthy Term Infants, Infant Formula, Infant Development, Child Development