A groundbreaking clinical trial led by Stanford Medicine has found that about one third of children with multiple food allergies can safely eat full servings of foods that once triggered life threatening reactions. The study offers new hope for families navigating the constant fear of accidental exposure to common allergens like peanuts, milk, eggs and wheat.
The research builds on the February 2024 approval of omalizumab by the U.S. Food and Drug Administration, which protects patients from severe reactions after accidental exposure to small amounts of allergens. In this second stage of the trial, scientists tested whether the injectable drug alone or combined with oral immunotherapy could allow children to regularly eat foods that previously caused dangerous allergic responses. The goal was rigorous: participants had to tolerate full 2,000-mg servings of three different allergy triggering foods, including peanuts, by the study’s end.
Among 117 children with a median age of 7, all of whom had a peanut allergy and at least two other food allergies, 36 percent of those receiving only omalizumab successfully met the tolerance threshold. In the group that received eight weeks of omalizumab followed by oral immunotherapy, 19 percent reached the same goal. The lower success rate in the combination group was largely due to more participants dropping out, often because of side effects or the demanding schedule of oral immunotherapy. “For people who could comply with the combined treatment approach, they were as successful as the patients using omalizumab alone,” said Dr. Sharon Chinthrajah, the study’s senior author and co director of the Sean N. Parker Center for Allergy and Asthma Research at Stanford Medicine.
Tailoring Treatment to Each Child’s Needs
Food allergies affect 8 percent of U.S. children and 10 percent of adults, and about 40 percent of kids with allergies react to more than one food. Until now, strict avoidance was the only option, making social events like birthday parties and school lunches stressful. Oral immunotherapy, which involves eating tiny, gradually increasing daily doses of allergens, has been used for about 16 years but requires frequent doctor visits, can cause gastrointestinal side effects, and demands that patients reduce physical activity for an hour after each dose. The new findings give doctors and families more flexible choices.
Dr. Chinthrajah emphasized that food allergy therapy is not one size fits all. She said she asks families detailed questions to determine the best approach: whether the child has one or multiple allergies, whether the goal is to eat the food freely or just avoid accidental reactions, and whether needle phobia or other allergic conditions like asthma or eczema might influence treatment. “Initially, families often want protection from accidental exposure,” she said. “Then, as they see that the maintenance is feasible, their goals might change.”
The research team, which included scientists from Johns Hopkins, Mount Sinai, Massachusetts General Hospital and other institutions, plans to further investigate why some participants discontinued treatment. The ultimate aim is to tailor care so that more children can live safely with food allergies, whether that means eating a full peanut butter sandwich or simply enjoying a birthday party without fear.