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

Abstract

BACKGROUNDThe 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. METHODSWe 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 (standardintroduction group). The primary outcome was food allergy to one or more of the six foods between 1 year and 3 years of age. RESULTSIn 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 standardintroduction 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. CONCLUSIONSThe 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.

Late introduction of fish and eggs is associated with increased risk of allergy development – results from the FARMFLORA birth cohort

“…The protective effect of growing up on a small, family-owned dairy farm is in line with previous studies [2,4,36]. Recent randomized trials point to postponement of introduction of solid foods as a strong risk factor for development of food allergy [15,16] and several observational studies have pointed to delayed introduction of fish as predictive of high risk of becoming allergic [22–29]. To the best of our knowledge, practices of introducing complementary foods have not been investigated previously in children of farming families.…”

“…However, nuts were introduced significantly earlier to the diet of farm children, and peanuts tended to be introduced earlier among the farmers. Delayed introduction of nuts [37], and peanuts [15,16], have previously been linked to an increased risk of developing allergy. However, the 0.01 < 0.05 P -value may be subjected to type I errors due to multiple comparisons.…”

“…Moreover, Filipiak and coworkers observed a higher risk of eczema in the first 4 years in children who had eggs introduced after 1 year of age [37]. In a large, randomized, controlled intervention of three-month-old infants, early introduction of eggs reduced the risk of egg allergy [16]. …”

“…According to national recommendations, mothers in Sweden are advised to breastfeed exclusively for a period of 6 months [14]. However, such recommendations are in conflict with two recent randomized controlled studies [15,16]. One of the studies showed that introduction of peanuts between four and 11 months of age to high-risk infants dramatically reduced their risk of peanut allergy development [15].…”

“…One of the studies showed that introduction of peanuts between four and 11 months of age to high-risk infants dramatically reduced their risk of peanut allergy development [15]. The other study was conducted on the general population and showed that consumption of 2 g of protein from peanut or egg-white per week from the age of 3 months was associated with a lower prevalence of these respective allergies than was less consumption [16]. These findings agree with observations from studies in experimental animals; oral tolerance is induced to proteins fed in quite large amounts, while feeding miniscule amounts of foreign proteins may instead result in sensitization and allergy [17,18].…”