New Safety And Tolerance Data: Single vs Multi-Allergen Introduction

In February, foundational research supporting the early development of recipes for SpoonfulONE titled, “Early Introduction of Multi-Allergen Mixture for Prevention of Food Allergy: Pilot Study” was published in the journal  Nutrients. Conducted out of the Sean N. Parker Center for Allergy and Asthma Research at Stanford University, the 1-year pilot study evaluated the safety and efficacy of single, double, and multiple food allergen introduction in infants for the prevention of food allergy. It found a multi-food protein blend to not only be well-tolerated but also effective in building immune tolerance to common food allergens.

In the study, 180 healthy infants were randomized (and stratified by risk for food allergy) into 3 active feeding groups (single, double, mixed) vs a control group. Infants in the active feeding groups were then further randomized into specific allergen groups and fed daily servings of the following for 1 year:

*10 food allergens: Milk, Egg, Peanut, Cashew, Almond, Shrimp, Walnut, Wheat, Salmon, Hazelnut

After 1 year, plasma biomarkers associated with food reactivity (IgE, IgG4, and ratio of IgG4/IgE) were evaluated to understand differences in the safety of single, double, and multi-food protein blends. Infants were then again evaluated for tolerance after 2-4 years by standardized food challenges which consisted of several escalating doses of the food protein every 15 minutes, as tolerated.  

The results demonstrated:

• Regardless of initial risk for food allergy, infants were able to tolerate the early introduction of multiple allergenic foods without an increase in safety events 
• The IgG4/IgE ratios for all mixed protein groups increased, which in numerous immunotherapy studies have been shown to be suggestive of tolerance
• Infants who received multiple allergen mixtures demonstrated improved tolerability in food challenge reactivity rates compared to single and double food groups