Roughly 8% of US children have food allergies, some of which can trigger severe or life-threatening reactions, according to the National Institute of Allergy and Infectious Disease (NIAID). Peanut and egg are among the most common allergens in early childhood.
The National Institutes of Health (NIH) has initiated a novel clinical trial – called ESCAPE (Expecting Mother’s Study of Consumption or Avoidance of Peanut and Egg) – to explore the development of sensitization or tolerance to these foods in infants based on maternal consumption or avoidance during pregnancy and breastfeeding.
If successful, the trial could pave the way for earlier, evidence-based strategies to help prevent food allergies in children most at risk, potentially reducing the prevalence of severe allergic reactions in future generations.
Why this study matters
At the moment, there is no known cure for food allergies, at least two in five children (40%) have been treated in emergency departments for reactions, according to CDC data. Between 1997 and 2007, the CDC also documented an 18% rise in food allergies among Americans under 18. While NIAID researchers have identified risk factors, the exact cause of this increase remains unknown.
“Introducing food allergens such as peanut and egg into infants’ diets around four to six months of age has proven to be an important element of food allergy prevention, but this intervention comes too late for some children,” said Alkis Togias, chief of NIAID’s Allergy, Asthma and Airway Biology Branch in a release. “We need additional, earlier strategies to help prevent the development of food allergies in children at high risk for them.”
Study details and participants
The ESCAPE trial will enroll 500 pregnant women –between confirmed pregnancy and 27 weeks of gestation – who plan to exclusively breastfeed healthy infants. Eligible participants must not be allergic to peanut or egg themselves but must have babies at high risk for food allergy due to a parent, sibling or child with allergic disease such as asthma, eczema or food allergy.
About 25% of participants will be recruited locally in Rochester, New York, with the remainder drawn from across the United States. Led by Kirsi Järvinen-Seppo, chief of Pediatric Allergy and Immunology at University of Rochester Medicine, the national study will run until results are available in 2029.
How it works
ESCAPE is a parallel, two-arm, single-blinded randomized controlled trial. Mothers will be randomly assigned to either consume or avoid peanut and egg starting in their third trimester and continuing through breastfeeding. Investigators will provide guidance on weekly intake or on strict avoidance, depending on the assigned group.
Mothers will be encouraged to exclusively breastfeed for at least the first three months. Study staff – and those analyzing the results – will not know which mother-infant pairs are in the consumption or avoidance groups.
The primary goal is to determine the proportion of infants in each group who have detectable levels of IgE antibodies to peanut, egg or both by the age of 4 to 6 months – before the babies have eaten these foods.
Looking forward
The ESCAPE trial is currently recruiting participants and invites expectant mothers who meet the eligibility criteria to join the study. By examining how maternal consumption or avoidance of peanuts and eggs during pregnancy and breastfeeding influences infants’ early immune responses, researchers hope to uncover new insights into the development of food sensitization.
