The National Institutes of Health has launched a groundbreaking clinical trial to determine whether maternal consumption of peanuts and eggs during pregnancy and breastfeeding can prevent the development of early food allergy markers in high-risk infants. The study, known as the Expecting Mother's Study of Consumption or Avoidance of Peanut and Egg (ESCAPE), represents a novel approach to food allergy prevention that targets the prenatal and early postnatal periods.
Food allergies affect approximately 8% of children in the United States and can cause severe or life-threatening reactions. Peanuts and eggs rank among the most common early-childhood food allergens, making them critical targets for prevention research.
Addressing Pre-Exposure Sensitization
The trial addresses a significant gap in current food allergy prevention strategies. While introducing allergenic foods like peanuts and eggs into infants' diets around four to six months of age has proven effective for prevention, this approach comes too late for some children.
"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. "We need additional, earlier strategies to help prevent the development of food allergies in children at high risk for them."
Research has revealed that some infants' immune systems produce immunoglobulin E (IgE) antibodies against peanuts and eggs before they ever consume these foods. This antibody serves as a precursor to food allergy development, indicating the need for prevention strategies that begin before solid food introduction.
Trial Design and Methodology
The ESCAPE trial will enroll 504 mother-infant pairs across multiple sites, with one quarter participating at University of Rochester Medicine in Rochester, New York, and three quarters at locations nationwide. The study targets pregnant mothers who are not allergic to peanuts or eggs but whose babies face high risk for food allergies due to family history of allergic disease in a parent, sibling, or child.
Participants will be randomly assigned to either consume or avoid peanuts and eggs, beginning in their third trimester and continuing throughout breastfeeding. Investigators will provide specific guidance on weekly consumption amounts for the intervention group or avoidance strategies for the control group. Mothers will be encouraged to exclusively breastfeed their infants for at least three months.
The study employs a double-blind design, ensuring that investigators and data analysts remain unaware of group assignments during assessment and analysis phases. Mother-infant pairs will be monitored until the children reach one year of age.
Primary Endpoints and Expected Outcomes
The trial's primary objective is to determine the proportion of infants in each group who develop IgE antibodies against peanuts, eggs, or both by 4 to 6 months of age, before they consume these foods. This measurement will provide crucial evidence about whether maternal dietary interventions during pregnancy and breastfeeding can influence early immune system development.
The study will be led by Kirsi Järvinen-Seppo, M.D., Ph.D., chief of Pediatric Allergy and Immunology and Founders' Distinguished Professor in Pediatric Allergy at University of Rochester Medicine. Results are anticipated in 2029.
Scientific Rationale
Previous research examining the relationship between maternal consumption or avoidance of allergenic foods during pregnancy and breastfeeding and subsequent food allergy development in infants has yielded contradictory results. The ESCAPE trial aims to provide definitive evidence regarding the efficacy of including peanuts and eggs in expecting mothers' diets as a prevention strategy.
The trial is funded by NIH's National Institute of Allergy and Infectious Diseases (NIAID), which conducts and supports research on infectious and immune-mediated diseases worldwide. The study is registered at ClinicalTrials.gov under identifier NCT06260956, with contact information available for interested participants.
