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Published on: September 20, 2019
Randomized Trial of Introduction of Allergenic Foods in Breast-Fed Infants
Michael R Perkin1, Kirsty Logan1, Anna Tseng1
1From the Population Health Research Institute, St. George's, University of London (M.R.P.), the Department of Paediatric Allergy, Division of Asthma, Allergy, and Lung Biology, King's College London and Guy's and St. Thomas' NHS Foundation Trust (M.R.P., K.L., A.T., B.R., H.B., T.M., S.R., J.C., C.F., G.L.), the Division of Health and Social Care Research, King's College London (S.A., J.P.), and the St. John's Institute of Dermatology, Guy's and St. Thomas' NHS Foundation Trust (C.F.) - all in London.
Insights
Early introduction of allergenic foods did not prevent food allergy in an initial analysis. However, a secondary analysis suggested a potential dose-dependent protective effect for peanut and egg allergies.
Area of Science:
- Pediatric Allergy and Immunology
- Infant Nutrition
- Public Health
Background:
- The optimal timing for introducing allergenic foods to breast-fed infants remains unclear.
- Concerns exist regarding the development of food allergies in infants.
- This study addresses the uncertainty surrounding early allergen introduction and its impact on food allergy prevention.
Purpose of the Study:
- To evaluate the efficacy of early introduction of six allergenic foods in preventing food allergy in exclusively breast-fed infants.
- To compare early allergen introduction with standard UK infant feeding guidelines.
Main Methods:
- A randomized controlled trial involving 1303 exclusively breast-fed infants at 3 months of age.
- Infants were assigned to either early introduction of peanut, egg, milk, sesame, fish, and wheat, or standard exclusive breast-feeding until 6 months.
- The primary outcome was the development of food allergy to one or more of the six foods between 1 and 3 years of age.
Main Results:
- The intention-to-treat analysis showed no significant difference in overall food allergy rates between groups (7.1% standard vs. 5.6% early).
- Per-protocol analysis revealed significantly lower rates of any food allergy (7.3% vs. 2.4%), peanut allergy (2.5% vs. 0%), and egg allergy (5.5% vs. 1.4%) in the early-introduction group.
- Consumption of specific amounts of peanut or egg protein was associated with reduced allergy prevalence; early introduction was safe but challenging to implement fully.
Conclusions:
- The study did not demonstrate the efficacy of early introduction of multiple allergenic foods in an intention-to-treat analysis.
- Further analysis suggests a potential dose-dependent relationship between early allergen exposure and reduced risk of specific food allergies, particularly peanut and egg.
- The findings raise questions about the optimal strategy for preventing food allergies through early dietary interventions.
Background:
The age at which allergenic foods should be introduced into the diet of breast-fed infants is uncertain. We evaluated whether the early introduction of allergenic foods in the diet of breast-fed infants would protect against the development of food allergy.
Methods:
We recruited, from the general population, 1303 exclusively breast-fed infants who were 3 months of age and randomly assigned them to the early introduction of six allergenic foods (peanut, cooked egg, cow's milk, sesame, whitefish, and wheat; early-introduction group) or to the current practice recommended in the United Kingdom of exclusive breast-feeding to approximately 6 months of age (standard-introduction group). The primary outcome was food allergy to one or more of the six foods between 1 year and 3 years of age.
Results:
In the intention-to-treat analysis, food allergy to one or more of the six intervention foods developed in 7.1% of the participants in the standard-introduction group (42 of 595 participants) and in 5.6% of those in the early-introduction group (32 of 567) (P=0.32). In the per-protocol analysis, the prevalence of any food allergy was significantly lower in the early-introduction group than in the standard-introduction group (2.4% vs. 7.3%, P=0.01), as was the prevalence of peanut allergy (0% vs. 2.5%, P=0.003) and egg allergy (1.4% vs. 5.5%, P=0.009); there were no significant effects with respect to milk, sesame, fish, or wheat. The consumption of 2 g per week of peanut or egg-white protein was associated with a significantly lower prevalence of these respective allergies than was less consumption. The early introduction of all six foods was not easily achieved but was safe.
Conclusions:
The trial did not show the efficacy of early introduction of allergenic foods in an intention-to-treat analysis. Further analysis raised the question of whether the prevention of food allergy by means of early introduction of multiple allergenic foods was dose-dependent. (Funded by the Food Standards Agency and others; EAT Current Controlled Trials number, ISRCTN14254740.).
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