Validation of a Proprietary Test Strip for the Detection of Bovine and Soy Proteins in Human Milk: a Randomized Crossover Study

The current estimated prevalence of Immunoglobulin E-mediated childhood food allergy is ~8% with up to 11% of caregivers reporting food allergy symptoms. Research also suggests that 40% of children with food allergy report food allergy to multiple food allergens. Infant food allergy can result in multiple physical symptoms including colic, vomiting, reflux, bloody stool, failure to thrive, and eczema, and has been associated with a decreased quality of life in infants and their caregivers. Treatment options for infant food allergies are currently limited. In most situations, mothers must choose between continuing to breastfeed while attempting to avoid potential food allergens or ending breastfeeding and providing expensive hydrolyzed infant formula.

Breastfeeding affects mortality in children under the age of 5 years old reducing episodes of diarrhea and respiratory infections, and decreasing hospital admissions by up to 70%. The Lancet series on breastfeeding quantified the global economic health impact of breastfeeding on healthcare due to infant illness and mortality. Of the estimated 130 million live births per year globally, 820,000 infant deaths, 87% of which are under 6 months old, could be mitigated with improved breastfeeding practices. The Lancet report projects that a 10% increase in exclusive breastfeeding up to 6 months would translate to an estimated $312 million in healthcare savings in the US alone. Long-term (up to 2 years), additional breastfeeding benefits would impact treatment costs for infants and toddlers as much as $2.45 billion in the US.

Many breastfeeding women are led to believe that they should not eat certain foods (e.g., dairy) because this might lead to food intolerance in their infants. Without a method to directly test human milk, mothers will methodically cut out whole food groups (most of them extremely healthy) without realizing that the true problem is going undetected. This often starts with dairy and quickly spirals until her diet is very limited. A total elimination diet is typical for this community. Many women reduce their intake down to as few as five foods (i.e., chicken, mango, coconut oil, spinach, and potato). This extreme dietary restriction puts mothers and infants at risk for nutritional deficiencies with potential life-long effects.

Currently, there is no mechanism available for mothers to know what allergens are present in their milk. Food diaries are inadequate as dietary protein only enters breastmilk a portion of the time and is present in the milk for a variable amount of time depending on several factors including metabolism, nursing schedule and unknown individual characteristics. A simple at-home test strip would empower women to continue breastfeeding by removing the mystery of the allergens present. Mothers and pediatricians could use this information to determine what is causing reactions and then follow up to determine if informed dietary elimination made mom's milk safe. Women could then enjoy their favorite foods and be confident in feeding their infant.

Free to Feed has developed a first-in-class solution using patent-pending technology to detect food allergen proteins in human milk. With this knowledge, mothers would be able to identify the culprit and remove the food from their diets or wait for the allergen to clear from their milk prior to feeding through repeated testing. This technology hopes to empower mothers to breastfeed longer, giving both mom and baby lifelong benefits, while relieving the stress of inducing unknown effects.