Randomized Trial of Introduction of Allergenic Foods in Breast-Fed Infants

Flora Le, Mercer University College of Pharmacy

According to the Australian Society of Clinical Immunology and Allergy, there is no need to avoid allergenic foods in children four to six months old.  [1]

The more recently published guidelines by the European Academy of Allergy and Clinical Immunology’s Taskforce on Prevention states that there is no need to avoid introducing complementary foods beyond four months of age and that current evidence does not justify recommendations about withholding or encouraging exposure to potentially allergenic foods after four months.  [3]

Title: Randomized Trial of Introduction of Allergenic Foods in Breast-Fed Infants
Design Randomized, controlled, single site trial; N= 1,303
Objective To evaluate whether the early introduction of allergenic foods in the diet of breast-fed infants would protect against the development of food allergy
Study Groups Standard-introduction group (n= 651); early-introduction group (n= 652)
Methods From the general population, 1,303 exclusively breast-fed infants three months of age were randomly assigned to either the standard-introduction group or the early-introduction group.  Participants in the standard-introduction group were to be exclusively breast-fed to approximately 6 months of age. Participants in the early- introduction group were introduced to the consumption of allergenic foods (peanuts, cooked egg, cow’s milk, sesame, whitefish, and wheat).  Infants in the early-introduction group who had a wheal of any size on skin-prick testing at baseline underwent an open-label incremental food challenge totaling 2 g of protein of that food.
Duration November 2, 2009, to July 30, 2012
Primary Outcome Measure Food allergy to one or more of the six foods between 1 year and 3 years of age
Baseline Characteristics Standard Introduction group Early introduction group
Per protocol

(n= 558)

Non per- protocol
(n= 48)
Adherence- non evaluable
(n= 45)
Per protocol

(n= 223)

Non per- protocol
(n= 306)
Adherence- non evaluable
(n= 123)
Male, (%) 49.5 45.8 31.1 49.3 53.6 52.0
Ethnicity (non- white), (%) 15.1 16.7 26.7 7.2 16.3 23.6
Pet ownership, (%) 43.4 58.3 45.5 45.7 39.5 33.6
Visible eczema, (%) 24.2 25.0 22.7 20.2 28.1 23.6
Birth weight, (mean kg) 2.55 3.53 3.54 3.57 3.57 3.58
Caesarean delivery, (%) 21.9 20.8 35.6 24.7 29.1 29.3
Maternal asthma, (%) 27.1 22.9 27.3 26.5 28.1 18.9
Maternal atopy, (%) 63.3 60.4 65.9 60.1 64.7 58.2
Paternal atopy, (%) 57.0 50.0 45.5 51.1 51.0 48.4
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 and in 5.6% of those in the early-introduction group (p= 0.32).  In the per-protocol analysis, the prevalence of any food allergy in the early-introduction group was 2.4% and in the standard introduction group was 7.3% (p= 0.01).
Adverse Events Common Adverse Events: N/A
Serious Adverse Events: N/A
Percentage that Discontinued due to Adverse Events: N/A
Study Author Conclusions The trial did not show the efficacy of early introduction of allergenic foods in an intention-to-treat analysis.

The results from this study did not strengthen the necessity of introducing allergenic foods early on to infants in order to decrease the risk of food allergies later on.  The main limitation of the study was the low rate of per-protocol adherence in the early-introduction group as compared to the standard- introduction group.  Further studies analyzing the introduction of allergenic foods in both breast-fed and formula fed infants and should be completed.


  1. American Academy of Pediatrics, Committee on Nutrition. Hypoallergenic Infant Formulas. Pediatrics 2000; 106: 346-9.
  2. Australian Society of Clinical Immunology and Allergy. Infant feeding advice. 2010 (http://www.allergy.org.au/images/stories/hp/info/ASCIA_Infant_Feeding_Advice_2010.pdf)
  3. Muraro A, Halken S, Arshad SH, et al. EAACI Food Allergy and Anaphylaxis Guidelines. Primary prevention of food allergy. Allergy 2014; 69: 590-601.
  4. Perkin MR, Logan K, Tseng A, et al. Randomized Trial of Introduction of Allergenic Foods in Breast-Fed Infants. N Engl J Med. 2016;





One thought on “Randomized Trial of Introduction of Allergenic Foods in Breast-Fed Infants

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