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Randomized Controlled Trial of Early Introduction of Allergenic Foods to Induce Tolerance in Infants

Institutions
University of London - King's College
Start date
2008
End date
2014
Objective

There is currently a lack of consensus on when is the best time to introduce allergenic foods into the infant diet in order to minimise the risk of development of later allergic disease, including food allergy. The UK Government currently recommends that infants are exclusively breastfed until six months of age, and that certain foods that can cause allergic reactions in some babies (e.g. egg, wheat, peanuts, tree nuts, seeds, fish and shell fish) are best avoided before six months of age.

However, the advice regarding exclusive breastfeeding until 6 months was primarily formulated on nutritional grounds. It is currently unclear whether this same advice is best from the point of view of minimising risk of development of allergies. Recent research has suggested that delayed introduction of food allergens may not be as protective as previously thought and there is some preliminary evidence from human and animal model studies suggesting that high dose oral exposure to food proteins in early life might prevent the development of allergic sensitisation. There is therefore a real need to conduct further research in this area to help the Agency to formulate sound advice to mothers about dietary introduction of allergenic foods.

More information
This randomised controlled intervention study aims to explore the effect of early introduction (from 3 months of age) of allergenic foods on the later development of food allergy, in infants from the general population.

The study plans to recruit 3000 mothers during pregnancy to participate in the study. Once babies are born, all mothers will be encouraged to breast feed exclusively until three months of age, but, after this point the infants will be randomly split into two arms of the study. One half (the intervention arm) will introduce sequentially, a number of allergenic foods (egg, milk, wheat, soya, fish and peanut) into the diet under close dietetic direction. The other half (the control arm) will be encouraged to follow the current Government weaning advice of exclusive breastfeeding until 6 months of age. Both arms will be encouraged to breast feed for at least six months and the study will follow the Department of Health Infant Feeding Recommendation that breast milk "should continue to be an important part of babies' diet for the first year of life".

Participants will be followed up to 3 years of age when the impact of the intervention on food allergy and other secondary allergy endpoints (eczema prevalence, inhalant allergen sensitisation, atopic wheeze, phenotype and combined allergy prevalence) will be assessed.

Find more about this project and other FSA food safety-related projects at the Food Standards Agency Research webpage.

Funding Source
Food Standards Agency
Project source
View this project
Project number
T07051
Categories
Sanitation and Quality Standards
Commodities
Nuts, Seeds