New Study Shows Gradual Peanut Butter Intake Can Desensitize Children with High-Threshold Peanut Allergies.
A new clinical trial led by researchers at the Icahn School of Medicine at Mount Sinai has found that children with high-threshold peanut allergies—those who can already tolerate at least half a peanut—can safely increase their tolerance through gradually escalating doses of store-bought peanut butter. The findings, published in the February 10 issue of NEJM Evidence, suggest a promising, low-cost alternative to conventional pharmaceutical-grade therapies.
Traditionally, managing food allergies has meant strict avoidance. However, in recent years, oral immunotherapy (OIT)—a process involving controlled exposure to increasing amounts of an allergen—has gained attention, particularly for patients with low-threshold allergies. Previous FDA-approved treatments focused on individuals highly sensitive to even minuscule amounts of peanut protein. In contrast, this new research targets a different population—an estimated 800,000 children in the U.S. who react only to larger quantities of peanuts.
“This study offers a new treatment pathway that is safe, affordable, and potentially life-changing for children with peanut allergies who already tolerate small amounts,” said Dr. Scott Sicherer, the study’s lead author and Director of the Jaffe Food Allergy Institute at Mount Sinai Kravis Children's Hospital. “It supports a more personalized approach to managing food allergies based on individual thresholds.”
To evaluate the method, 73 children aged 4 to 14 were randomly divided into two groups: one that avoided peanuts and another that gradually consumed increasing amounts of peanut butter. Starting with just 1/8 teaspoon per day, the ingestion group increased their intake every eight weeks under medical supervision, ultimately reaching one tablespoon by the end of the 18-month study.
Importantly, none of the children in the treatment group experienced severe allergic reactions during home dosing. Only one participant required epinephrine during a supervised session. After completing the regimen, children in the peanut-consuming group underwent a supervised food challenge to assess how much peanut protein they could safely tolerate. All 32 children from this group who took the test tolerated up to nine grams of peanut protein—the equivalent of about three tablespoons of peanut butter. In contrast, only three of 30 children in the avoidance group reached this level.
Because the trial took place during the COVID-19 pandemic, some families opted out of in-person testing. Researchers applied statistical methods to account for these absences and concluded that 100% of the treatment group and 21% of the avoidance group could tolerate at least two more doses than they could at the beginning of the study.
To assess the durability of the treatment, children who tolerated nine grams of peanut protein were asked to consume at least two tablespoons of peanut butter weekly for 16 weeks, followed by an eight-week period of complete peanut avoidance. Afterward, 26 of the 30 children tested were still able to consume the full nine grams without any reaction. In contrast, only the three participants from the avoidance group who had earlier reached this level maintained their tolerance, indicating they may have developed it naturally.
Overall, 68.4% of the children in the treatment group achieved sustained unresponsiveness, compared to just 8.6% in the control group.
“This is an exciting step toward more personalized food allergy therapies,” said Dr. Sicherer. “It has the potential to reshape clinical practice for children with food allergies, not just to peanuts, but eventually other allergens as well.”
The research team, which includes co-senior author Dr. Julie Wang, now aims to explore how to better identify children with higher thresholds without relying on oral food challenges, which carry a risk of triggering allergic reactions. They also plan to expand their studies to include other common food allergens.
Source:https://www.sciencedaily.com/releases/2025/02/250210132138.html
This is non-financial/medical advice and made using AI so could be wrong.