Ready. Set. Food! for Preventing Food Allergies
(EASE Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial investigates whether Ready. Set. Food! supplements can help prevent food allergies in infants. The study compares infants receiving these allergen introduction supplements to those following typical pediatric advice. The goal is to simplify the introduction of common allergens like milk, eggs, and peanuts, reducing the risk of developing food allergies. Full-term babies aged 2-5 months, without known allergies to these foods, may be suitable for this trial. As an unphased trial, it offers parents a unique opportunity to contribute to important research that could simplify allergen introduction for future families.
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 prior data suggests that Ready. Set. Food! is safe for infants?
Studies have shown that introducing common allergens like peanuts, eggs, and milk early in a child's life can prevent up to 80% of food allergies. This concept underlies Ready. Set. Food!, a product that helps parents easily incorporate these allergens into a baby's diet. Research indicates that giving small, controlled amounts of these allergens is generally safe for infants.
Ready. Set. Food! introduces these allergens gradually and one at a time, enhancing safety. Over 200,000 infants have used this product without widespread reports of severe problems, suggesting it is well-tolerated by most children. While monitoring for allergic reactions when introducing new foods is crucial, available evidence supports the safety of Ready. Set. Food! in preventing food allergies.12345Why are researchers excited about this trial?
Researchers are excited about Ready. Set. Food! because it offers a novel approach to preventing food allergies by introducing allergens early in a child’s diet. Unlike standard treatments that usually involve managing symptoms after allergies develop, this method aims to proactively reduce the risk of allergies altogether. The unique feature here is the early allergen introduction supplement, which could potentially change the way we think about allergy prevention.
What evidence suggests that Ready. Set. Food! could be effective for preventing food allergies?
Research shows that introducing common allergens such as peanuts, eggs, and cow's milk to infants early can lower their risk of developing food allergies. Studies have found that introducing these foods before six months of age significantly reduces the chances of allergies later. In this trial, participants in the intervention group will receive Ready. Set. Food!, an easy-to-use supplement containing these allergens. Over 200,000 infants have used this product, which follows the effective amounts used in clinical trials. This method aims to simplify early allergen introduction for parents, and previous trials support its success in reducing food allergies.36789
Who Is on the Research Team?
Kara McNamara, MD
Principal Investigator
ObvioHealth
Vikram Garg, MD
Principal Investigator
Curavit
Are You a Good Fit for This Trial?
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 for a Trial Participant
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
What Are the Treatments Tested in This Trial?
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