Follow-up on the LEAP Study – Q&A with FARE CEO James R. Baker, Jr., MD

FARE has received many questions about the new findings from the Learning Early About Peanut Allergy study, recently published in the New England Journal of Medicine. Information about the study’s findings are available here.

To help address these questions and clear up some misperceptions about the study’s results, FARE CEO James R. Baker, Jr., MD weighs in with key takeaways from the study and what it means for our growing body of scientific knowledge about food allergy.

What did the LEAP study find?

This study showed that being introduced to peanut at an early age (before age 1) and regularly eating a peanut-containing snack reduced the likelihood of developing peanut allergy among children with certain risk factors for peanut allergy.

Why is this study important?

The LEAP study is very important because it is the first large-scale, prospective study to examine whether feeding infants specific food was likely to increase or decrease the risk of allergy. The size and scope of the study increases its quality and the likelihood that it will apply to a larger group of patients. While this topic has been explored in many smaller studies, they were neither large nor well-controlled enough to definitively answer the question.

Who did this study follow?

  • High-risk infants, defined as having eczema or egg allergy. The infants could have a positive skin test to peanut (wheal less than 4mm in diameter) as long as they were not clinically allergic.
  • Infants entered the study at 4-11 months of age and were followed until 5 years of age.
  • The study DID NOT follow infants who already had a peanut allergy or those who had a skin test resulting in a wheal larger than 4 mm in diameter.

Is this a new treatment for food allergy?

This is not a treatment for food allergy. This study specifically showed that feeding peanut early in life might prevent the development of food allergy in non-allergic children who are at risk for peanut allergy. This study did not examine the effect of feeding peanut to children who already have a peanut allergy. In fact, children with peanut allergy were specifically excluded from the study.

Does the method used in the LEAP study work to prevent peanut allergy for everyone?

Feeding this peanut candy three times a week reduced the likelihood of developing peanut allergy by approximately 75 percent in the patient population that was identified to participate (non-allergic, high-risk infants). However, while the feeding of peanut was effective in preventing many patients from developing peanut allergy, it did not prevent all patients from developing this allergy.

Does this study have any findings related to whether a mother’s diet during pregnancy had an effect on whether her child developed peanut allergies?

This study made no assessment of the effect of a mother’s diet on the development of peanut allergy.

This completely changes what I was told when introducing my children to solid foods – how did the medical and scientific community get things so wrong before?

The prior studies that examined feeding food were small and not definitive. The reason FARE supported this study was because we felt it was important to absolutely know whether feeding a potential allergen to children at risk for food allergy was a good or bad idea. Because of the large nature of the study and the long period of exposure, this is the first definitive answer for this question.

The news headlines about this study seem to imply that I should start feeding peanut products to my infant – is that true?

Many of the news headlines surrounding the study were inaccurate and have caused pain and consternation among parents of young children. If your child has no risk for peanut allergy, it is probably safe to feed him or her peanuts. If your child has risk for peanut allergy, such as eczema, egg allergy or a family history, an allergist should evaluate him or her before peanut is introduced. If your child is allergic to peanut, you should never feed him or her peanut unless your child is receiving the allergen under a physician’s supervision in a controlled clinical study.

Besides food introduction, what other factors are at play when it comes to developing food allergies?

Many factors are thought to contribute to the development of food allergy. Environmental factors such as environmental food dust, genetic factors and other as yet unknown issues all play a role in the development of food allergy.

People outside the food allergy community appear to be using the study findings as fodder to blame parents for their kids having food allergies – what’s the best response to this?

The best response is to point out that this study did not prevent food allergy in children who were already allergic and did not prevent all food allergy in children who were assigned to eat peanut. It is also important to remind people that peanut allergy is something that can happen to any child — and it’s critical for everyone to not only try to prevent reactions but also be accommodating to children who already have peanut allergy. It is also crucial to develop effective therapies that will allow children with peanut allergies – and other food allergies — to be safe.  FARE is working with the academic and pharmaceutical communities to help develop therapies to treat children with food allergies.

13 thoughts on “Follow-up on the LEAP Study – Q&A with FARE CEO James R. Baker, Jr., MD

  1. I’m so perplexed by the latest research suggesting that early exposure to peanuts may prevent allergy. My daughter was exposed almost daily in utero and through breast milk her first year. She had her first reaction at 12 months and several subsequent, anaphylactic reactions. She was clearly exposed to peanuts and developed a severe allergy. I strongly believe that while she may have been genetically predisposed to the allergy, the regular exposure in utero and through breast milk caused her allergy (it certainly did not prevent it). I would really like to hear one of the doctors involved in the studies explain her type of situation.

  2. Are there any studies being done to address the babies who have the allergy at birth? My son was born with multiple allergies.

  3. The children in the LEAP study were selected because they were ‘at risk’. In other words, children as young as 4 months of age were at risk of developing peanut allergy because they already had severe allergies to dairy or egg. The question remains: what is causing infants to be develop severe allergies to food? In examining the history of this epidemic we find that there was a window of time when everything changed for children. Suddenly, starting in the late 1980s through early 90s the numbers of anaphylactic children began to soar in specific countries and at the same time. …. what doctors including those involved in the LEAP study fail to point out is this crucial history. This sudden and specific onset just in kids and the massive rise from a virtually unknown issue to 2 million US children in just 20 years is the primary clue to understanding this epidemic. https://youtu.be/7qePXOlTBDg

  4. Why? It’s my belief that we’re looking at a perfect storm involving the widespread ingestion of antibiotics (both directly administered and also via sources such as dairy, meat and water supply); GMOs and their accompanying pesticides/herbicides; and a Western diet comprised heavily of processed foods. These factors negatively impact gut microbiome and thus the individual’s ability to properly digest food proteins.

    Let’s talk about vaccines because Heather Fraser mentions it via the You Tube jump she includes in her post. Vaccines have long been problematic for allergic individuals. Our immune systems are genetically prone to over react to “invaders,” real or often mistaken. And yet vaccines provide tremendous, lifesaving benefit in the form of herd immunity from which even, or perhaps particularly, allergic individuals benefit. (Imagine an asthmatic contending with pertussis.) I’m a fan. However, I will note that my children’s allergic symptoms began following their first series of vaccinations as infants. Vaccines didn’t cause their allergies; genes did. However it appears likely to me that vaccination was an environmental factor that flipped their genetic switch on. I’d rather manage a serious food allergy than watch my child become infected by or possibly die from a preventable disease. But what do we say to parents who have lost their children to food-induced anaphylaxis?

    As for the study, my peanut-allergic daughter who would have met the study criteria also was exposed to peanut protein in utero and via breast milk. She also ate PB&J prior to 12 months of age and subsequently suffered a significant reaction to PB&J the second time she ate it (classic development of food allergy). She was diagnosed at 10 months of age with a life-threatening peanut allergy that has since worsened in its intensity. She is now 13 and by God’s grace has never suffered another peanut-allergic reaction since the one that precipitated her diagnosis. Please note Dr. Baker’s comment above: “This study made no assessment of the effect of a mother’s diet on the development of peanut allergy.” No assessment of the mother’s diet! The mother’s diet is the child’s diet in utero. It’s not clear to me from Baker’s answer whether the study addressed the breastfeeding mother’s diet. It’s an incomplete study without data including the mother’s diet. Parents need answers, and while this study appears to offer promising guidance, it’s cold comfort to those of us who exposed our children to peanut protein prior to 12 months of age but still witnessed their subsequent development of severe peanut allergy. Old wisdom told us it was our fault; we introduced peanut too soon. This new wisdom says, “Sorry, your kid was one of the few who became allergic anyway.”

    Baker says, “Many factors are thought to contribute to the development of food allergy. Environmental factors such as environmental food dust, genetic factors and other as yet unknown issues all play a role in the development of food allergy.” Unknown issues? It’s been, what, over two decades? We have a generation of children impacted by lifelong, life-threatening food allergy. Can we please get some answers?

  5. re: this quote:

    “Many factors are thought to contribute to the development of food allergy. Environmental factors such as environmental food dust, genetic factors and other as yet unknown issues all play a role in the development of food allergy.”

    I find it very interesting that they completely avoid mentioning other potential factors such as the change in our food supply in the western world such as processing, roasting/cooking, GMO’s, irradiation, pesticides (food allergies are virtually non-existent in developing countries), the passing of antibodies through the mother’s milk (this is not genetics), the effects of the mother’s diet, and quite simply – having an impaired immune system.

    Even though the Peanut Board (who helped to fund the study) was not allowed to participate in the design of the study, there always exists a potential for bias (in this case reporting bias) when the results are published. I wouldn’t be surprised if food processing was omitted from this article due to the connection with The Peanut Board.

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