Atopic dermatitis is more commonly known as atopic eczema or eczema.
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Eczema is a chronic (life-long), inflammatory, itchy skin condition that presents in infants and early childhood. The condition typically fluctuates in severity between periods of flares and remissions. Eczema affects approximately 15-30% of children worldwide,^1^ with variability in prevalence and severity by country.^2^
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A family history of eczema is the most significant risk factor, increasing the risk by 2-3 times^3^. A family history means having at least one parent with eczema.
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There are various gene changes that affect the skin barrier and immune response, increasing the likelihood of eczema. Environmental factors, such as allergens and other irritants, can trigger and exacerbate symptoms, leading to flare-ups.
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Whole goat milk formula refers to infant or follow-on formula in which whole goat milk is used as the only source of protein and ~50% of fat is from milk fat, rather than relying on isolated milk proteins (skim milk and whey) or vegetable oils.
Its defining features include the preservation of the natural 20:80 whey-casein protein ratio of goat milk and retention of a high proportion of milk fat (~50%).
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This means that the whole goat milk formula:
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{small}ClinicalTrials.gov registration number: NCT04599946{/small}
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Infants were recruited before the age of 3 months and randomly assigned to receive whole goat milk formula or cow milk formula. Only healthy full-term infants whose parents had chosen to initiate formula feeding for reasons unrelated to the trial. There were no selection criteria related to the risk of atopic dermatitis. Caregivers and their child completed assessments at either in-person visits or phone calls every two months, up to the age of 12 months, and periodically thereafter.
The study is being undertaken by trained study personnel and principal investigators at each study site. Growth measures and adverse events are conducted in accordance with Good Clinical Practice. Precautions were taken to ensure that the recruitment process did not interfere with breastfeeding intention or practices.
For the primary outcome measure for atopic dermatitis, the required sample size of 1,722 infants was calculated based on an atopic dermatitis incidence of 15% and a 30% risk reduction. A dropout of up to 25% was initially assumed, leading to a planned enrollment of 2,296 infants. However, recruitment was stopped after reaching a total of 2,132 infants, as the observed dropout rate was lower than initially assumed.
{small}Adapted from Ferry, et al. 2023^4^{/small}
For the outcomes related to eczema, the participants were assessed for atopic dermatitis by several methods:
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Eczema is not simply a “rash” – it is a recurring, inflammatory condition with significant impact on children and their families.
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The other impacts of eczema include:
Eczema is not just a childhood disease. – Approximately 10% of infants and children with eczema will continue to experience eczema throughout their adulthood^1^.
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In addition, they are predisposed to other allergic diseases such as food allergies, asthma, and hay fever^5^. This is often referred to as the allergic march or multimorbidity.
Prevention is the most effective way to reduce the burden of eczema and the development of other allergic conditions.
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The GIraFFE Study is investigating whether Whole Goat Milk Formula can reduce the risk of developing atopic dermatitis/eczema compared to standard cow milk formula.
^1^ Bieber N Engl J Med 2008, 358, 1483-1494
^2^ Silverberg et al. Asthma & Immunology 2021, 126(4), 417-428
^3^ Ravn et al. J Allergy Clin Immunol 2020,145:1182-93
^4^ Ferry et al. BMJ open 2023, 13(4), e070533
^5^ Tsuge et al. Children 2021, 8(11), 1067
^6^ Chu et al. J Allerg Clin Immun 2024,12(7), 1695-1704
^7^ Li et al. Advances in Nutrition 2024, 15(5), 100217
^8^ Vandenplas et al. Journal of pediatric gastroenterology and nutrition 2024, 78.2: 386-413
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Manufactured in New Zealand by:
Dairy Goat Co-operative (N.Z.) Limited.
18 Gallagher Dr, Hamilton,
New Zealand.