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Early Allergen System Experience
Sponsor: Prollergy dba Ready Set Food
Summary
Multiple clinical trials have demonstrated that early allergen introduction, feeding babies common food allergens before six months, decreases children's risk of developing a food allergy. Despite successful food allergy introduction trials showing that food allergies can be prevented, early introduction in the required amount can be challenging for parents. In some studies, less than 20% of parents introduce peanuts before their child is six months old, and few feed them regularly after introduction. Ready. Set. Food! is a direct-to-consumer product that offers a convenient supplement with a daily dose regimen that can be added to breastmilk, formula, or food to make early allergen introduction easy. The formulation includes cow's milk, egg, and peanut, representing the majority of childhood food allergies, and the protein levels are based on doses found to be effective in clinical trials. Over 200,000 infants have used Ready. Set. Food!. This study investigates the effectiveness of introducing common allergens to infants with the goal of preventing food allergies. The study will enroll 1,100 infants stratified by their risk of developing a food allergy who are assigned to either receive Ready. Set. Food! supplements or follow standard allergen introduction practices recommended by their pediatrician. The goal of this study is to assess how Ready. Set. Food! allergen introduction supplements improve the experience of parents introducing allergens, decrease healthcare costs related to food allergies, and decrease food allergy prevalence.
Official title: Pragmatic, Randomized, Controlled Trial of Early Cow's Milk, Egg, and Peanut Allergen Introduction and Maintenance in Healthy and High-Risk Infants
Key Details
Gender
All
Age Range
2 Months - 5 Months
Study Type
INTERVENTIONAL
Enrollment
1110
Start Date
2024-03-07
Completion Date
2026-07-01
Last Updated
2025-06-05
Healthy Volunteers
Yes
Conditions
Interventions
Ready. Set. Food! Stage 1 Mix ins
These supplements contain cow's milk, eggs, and peanuts.
Locations (1)
Virtual Site Location - Curavit
New York, New York, United States