Ready. Set. Food! for Preventing Food Allergies
(EASE Trial)
Trial Summary
Will I have to stop taking my current medications?
The trial information does not specify whether participants must stop taking their current medications. However, it does exclude infants with certain medical conditions or those on chronic antibiotics, which might suggest some restrictions.
What data supports the effectiveness of the treatment Ready. Set. Food! for preventing food allergies?
How is the treatment Ready. Set. Food! different from other treatments for preventing food allergies?
Ready. Set. Food! is unique because it focuses on early exposure to allergenic foods in infants' diets as a strategy to prevent food allergies, which is different from the traditional approach of avoiding allergenic foods. This method aims to reduce the risk of developing allergies by introducing small amounts of potential allergens early on, rather than eliminating them from the diet.26789
What is the purpose of this trial?
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.
Research Team
Vikram Garg, MD
Principal Investigator
Curavit
Kara McNamara, MD
Principal Investigator
ObvioHealth
Eligibility Criteria
This trial is for caregivers of full-term, single-birth infants aged 2-5 months who are willing to use a smartphone app and follow study guidelines. It's aimed at those who can consent to the study's requirements and live with the infant throughout the trial. Infants at risk of developing food allergies may be included.Inclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Intervention
Participants receive an early allergen introduction supplement or follow standard practices
Follow-up
Participants are monitored for adverse events and adherence to allergen introduction
Treatment Details
Interventions
- Ready. Set. Food!
Find a Clinic Near You
Who Is Running the Clinical Trial?
Prollergy dba Ready Set Food
Lead Sponsor
ObvioHealth
Industry Sponsor