10 Things to Know About the LEAP Studies
1. The LEAP study was truly groundbreaking.
Prevention studies are difficult to fund. They also take years to yield results. But they are the only way to determine whether a prevention strategy really works.
Learning Early About Peanut Allergy was the first large study to look at early allergen introduction as a way to prevent food allergy. More than 500 young children participated in the trial.
LEAP showed that feeding peanut to high-risk infants early and often could prevent them from developing a peanut allergy. It reduced their risk by 81 percent, compared to a control group who avoided peanuts completely for the same five years. Learn more about the data.
A follow-up study (Persistence of Oral Tolerance to Peanut, or LEAP-On) proved that early peanut introduction continues to protect children from peanut allergy, even without daily peanut exposure. This suggests that the protection is long-lasting.
2. FARE was an early supporter of this research.
In 2008, FARE partnered with the National Institute of Allergy and Infectious Diseases (NIAID, a division of the National Institutes of Health) to fund this critical research as part of our commitment to advancing promising prevention strategies, treatments and cures for food allergy.
As the world’s largest private source of food allergy research funding, we have committed a total of $90 million to date.
3. Cultural differences in peanut consumption by children prompted this study.
A pediatric allergist and researcher, Dr. Gideon Lack, noticed the rate of peanut allergy was 10 times higher among Jewish children in the United Kingdom than Israeli children. This huge difference couldn’t be explained by genetics, socioeconomics or a tendency to develop other allergies.
But there is one relevant cultural difference between the two countries. In Israel, infants start eating peanut-containing foods when they are about 7 months old, and they continue to eat them as part of a regular diet. But in the UK, children usually don’t consume any peanut during their first year.
Dr. Lack wondered: Could early consumption be the key to preventing peanut allergy? He set out to answer this question as the lead investigator for LEAP and LEAP-On. About 10 years later, his work changed longstanding allergy guidelines — that’s fast in the scientific and medical world.
4. Conventional wisdom about when to introduce peanut has shifted over time. Conventional wisdom about when to introduce peanut was upended by LEAP and LEAP-On
Peanut allergy really started to rise in the 1990s. In the past 20 years we’ve seen a big shift in the recommendations we give to parents about introducing peanuts to an infant’s diet.
• In 2000, the American Academy of Pediatrics recommended high-risk children avoid peanuts until they reached 3 years old.
• In 2008, the Journal of Allergy & Clinical Immunology published Dr. Lack’s initial findings about the high prevalence of peanut allergy in British children compared to Israeli children.
• In 2010, NIAID said there wasn’t enough evidence to support the idea that waiting to feed children certain foods prevents food allergy. Their guidelines suggested feeding infants solid foods, which can include allergenic foods, no later than 4 to 6 months. But most pediatricians continued to recommend avoidance of peanut and other common allergens.
• In 2015, the results of the LEAP trial were published in the New England Journal of Medicine. LEAP-On came in 2016.
• By early 2017, NIAID officially changed its guidelines to support early introduction as a way to greatly reduce the risk for peanut allergy.
5. LEAP and LEAP-On studied only peanut allergy prevention.
This research excluded children with known peanut allergy to protect their safety. The results tell us nothing about treating people with food allergies.
All areas of food allergy research, education and advocacy are important. As research into food allergy prevention grows, other funds will continue to be invested toward finding treatments and cures for people with existing food allergies.
6. Early introduction does not prevent peanut allergy in all children.
Some children were already allergic to peanut at the time of the study and were excluded. These children had already developed a peanut allergy before their first birthday.
Other children in the study went on to develop a peanut allergy even though they started eating peanut in infancy. An 81 percent reduction in risk is very powerful, but the method is not guaranteed to work. This is partly because we don’t know all the mechanisms behind what causes food allergy.
7. More is on the horizon.
Researchers are exploring how early exposure to other common allergens affects rates of food allergy. LEAP gives us much hope, but we need to learn about each potential allergen with the same level of rigor.
8. This work was not sponsored by the peanut industry.
The vast majority of LEAP and LEAP-On funding came from the NIH and FARE. The National Peanut Board, a minority funder, was not allowed to influence any aspect of the study design or how the scientists interpreted the results.
Finally, the authors properly disclosed all the study’s funders and their conflicts of interest. This is best practice for any scientific research.
9. You should introduce peanuts based on your child’s risk level.
The NIAID feeding guidelines are as follows (ask your doctor if you are unsure about your child’s risk level):
- High risk (child has severe eczema, egg allergy or both): Introduce age-appropriate peanut-containing foods between 4 and 6 months. It’s a very good idea to have your child professionally tested for peanut allergy first (using either a skin prick test or blood test). This will help you decide whether to introduce peanut at home or in a healthcare setting.
- Moderate risk (child has mild or moderate eczema alone): Introduce age-appropriate peanut-containing foods at around 6 months. See your doctor if you have any specific concerns.
- Low risk (child has neither eczema nor food allergy): Introduce peanut-containing foods depending on your family’s preferences and cultural practices. This is considered safe and should lead to a lower rate of peanut allergy, compared with previous recommendations to avoid peanut.
Let your baby try other foods before you introduce anything with peanut. You want to make sure he or she is ready for solids.
Never give infants and small children whole peanuts or straight peanut butter, as they are choking hazards. Safe forms of peanut described in the NIAID feeding guidelines are Bamba (peanut butter-flavored corn puffs, manufactured by Osem), softened with water for younger babies; smooth peanut butter thinned with water; smooth peanut butter mixed with pureed fruits or vegetables; and peanut butter powder or peanut flour mixed with pureed fruits or vegetables.
10. Remember, anyone can develop a food allergy.
It’s no one fault when someone develops a peanut or other food allergy. Don’t feel guilty if it happens to you, your child or another family member.
We’re still learning about what causes food allergies, how to treat them and how to prevent them. As parents and healthcare professionals, we do the best we can do with the information we have at the time. And thanks to revolutionary research like the LEAP studies, we’re getting more answers every day.