A National Institutes of Health (NIH)-sponsored clinical trial testing whether maternal consumption of peanuts and eggs during pregnancy and breastfeeding prevents babies from developing an early sign of allergies to these foods began today. Food allergy affects about 8% of children in the United States and sometimes causes severe or life-threatening reactions. Peanut and egg are two of the most common early-childhood food allergens. The study will enroll pregnant mothers who are not allergic to peanut or egg but whose babies are at high risk for food allergy because the mother has a parent, sibling or child with allergic disease . NIH's National Institute of Allergy and Infectious Diseases (NIAID) is funding the trial.
"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."
Studies have found that before some infants ever eat peanut or egg products, their immune systems have already produced an antibody called immunoglobulin E (IgE) against these foods, and this antibody is a precursor of food allergy. These findings indicate a need to develop early childhood food allergy prevention strategies that precede the introduction of solid foods.
So far, research on the relationship between consumption or avoidance of allergenic foods by mothers during pregnancy and breastfeeding and the development of food allergy in their babies has yielded contradictory results. The new clinical trial aims to clearly determine the efficacy of including peanuts and eggs in expecting mothers' diets before and after birth to prevent their babies from developing IgE against those foods before they eat them.
The study team will enroll 504 mother-infant pairs, one quarter at University of Rochester Medicine in Rochester, New York, and three quarters elsewhere nationwide. The mothers will be assigned at random to either eat or avoid peanut and egg, beginning in their third trimester and continuing through breastfeeding. Investigators will provide guidance on the amounts of peanut and egg to eat weekly or guidance on how to avoid eating peanut and egg, as appropriate. Mothers will be encouraged to feed their infants breast milk exclusively for at least three months. The main goal of the study is to learn the proportion of infants in each group whose blood has IgE against peanut, egg or both at age 4 to 6 months, before they ever eat those foods.
Study investigators and others involved in assessing and analyzing the data will not know which mother-infant pairs are in the peanut and egg avoidance group and which are in the consumption group. Mother-infant pairs will be followed until the children turn 1 year old.
The study, called Expecting Mother's Study of Consumption or Avoidance of Peanut and Egg (ESCAPE), 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 expected in 2029.
