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ACTIVE NOT RECRUITING
NCT06262867
NA

Early Allergen System Experience

Sponsor: Prollergy dba Ready Set Food

View on ClinicalTrials.gov

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

Interventions

DIETARY_SUPPLEMENT

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