LOS ANGELES — Children who were fed six allergenic foods — peanut, egg, cow's milk, sesame, whitefish, and wheat — beginning at 3 months of age developed fewer food allergies, but the effect was only significant when the analysis was restricted to those who successfully followed a strict protocol.
This finding underscores the challenge of getting parents to introduce some foods, the researchers report.
"We did find that it was quite a hard ask for the families to adhere to all that food consumption in babies," Gideon Lack, MD, professor of pediatric allergy, Kings College in London, United Kingdom, said during a news conference.
"For those who managed to do what we intended, we did find a more than two-thirds reduction in the rate of food allergies, which is quite substantial," Dr Lack explained. However, "I don't think we can conclusively say that it was this intervention that brought down food allergies."
The research was presented here at American Academy of Allergy, Asthma and Immunology 2016 Annual Meeting and was published online simultaneously in the New England Journal of Medicine.
The study, known as Enquiring About Tolerance (EAT), is a successor to the Learning Early About Peanut (LEAP) study, which successfully induced tolerance in high-risk infants with the early introduction of peanut protein.
The EAT Study
To find out if the same approach would work in children in the general population, and with allergenic foods other than peanuts, Dr Lack and his colleagues randomized 1303 infants who were exclusively breast-fed to receive the allergenic foods or to maintain exclusive breast-feeding until the age of 6 months.
Adherence to the study protocol was considered to be successful if at least five of the six foods were consumed for a minimum of 5 weeks when the child was 3 to 6 months of age, and at least 75% of the recommended dose of 3 g of allergenic protein per week was consumed.
By the time the children were 1 to 3 years of age, fewer children in the allergenic food group than in the breast-fed group had developed allergies (5.6% vs 7.1%; P = .32).
In a per protocol analysis, the incidence of food allergy was significantly lower in the allergenic food group than in the breast-fed group (2.4% vs 7.3%; P = .01). For individual foods, the incidence of peanut allergy was significantly lower in the food group than in the breast-fed group (0.0% vs 2.5%; P = .003), as was the incidence of egg allergy (1.4% vs. 5.5%; P =.009). However, there was no significant difference between groups for allergy to cow's milk, whitefish, sesame, or wheat.
"There is the potential for this to change feeding practices, but I always recommend patients hold on and not jump onto anything too quickly " said Larry Posner, MD, an allergist and immunologist in Napa, California, who urged caution in acting on the results.
"We make the mistake too often of going 180 degrees," he told Medscape Medical News.
Dr Posner pointed out that the introduction of allergenic foods followed a strict protocol in this study. "Could we increase the incidence of allergies with hit-and-miss feeding without that structure?" he asked. Dr Lack indicated that they looked at that, but the study wasn't really powered to answer that question. "That's really the concern," Dr Posner said.
Dr Lack acknowledged that other causes could lead to the apparent effect. For example, if a child developed a subclinical egg allergy at 4 months and turned her head away from food, the parent might have given up feeding egg to her. That baby then could have been removed from the adherence group, which could have skewed the results.
"We don't think that was the case, but we don't know. The results are promising — I think exciting — and will require further confirmation in a study with greater adherence," Dr Lack explained.
"My view is that the effects of the early introduction of peanut are strong, durable, and it appears to work very well in both high-risk and general-risk populations. You can say, 'You can eat peanuts,' or you can say, 'You should eat peanuts.' I, frankly, think it should be the latter," he said.
Shaping Breast-Feeding Guidelines
Results from EAT and LEAP are likely to influence upcoming changes to breast-feeding guidelines. "They will clearly deviate from the notion of exclusive breast-feeding for 6 months," Daniel Rotrosen, MD, director of the division of allergy, immunology, and transplantation at the National Institute of Allergy and Infectious Disease, said during the news conference.
The key to success in reducing food allergy remains compliance, and that likely explains the discrepancy between the clear success of the LEAP trial and the guarded success of EAT. In LEAP, researchers were on the phone weekly with parents, helping them stick to the protocol.
"I remember calling up parents who were saying they wanted to stop because the baby's eczema was getting worse, and convincing them to keep going," said Dr Lack. "I was telling them, 'this has nothing to do with the eczema; we have a theory that it's the eczema that causes the food allergy'."
The EAT study had no such contact or support, he added.
Dr Lack, Dr Posner, Dr Rootrosen have disclosed no relevant financial relationships.
American Academy of Allergy, Asthma and Immunology (AAAAI) 2016 Annual Meeting. Presented March 4, 2016.
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Cite this: Early Introduction of Food Allergens Gets Mixed Results - Medscape - Mar 08, 2016.