Ready. Set. Food! for Preventing Food Allergies
(EASE Trial)

Recruiting in Palo Alto (17 mi)

Overseen byParth Shah, MD

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Prollergy dba Ready Set Food

No Placebo Group

Trial Summary

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.

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

I have given birth to one baby at full term.

I am the caregiver or legal guardian of the infant.

I will be living with the infant throughout the study.

+6 more

Participant Groups

The trial tests 'Ready. Set. Food!' supplements, which contain cow's milk, egg, and peanut proteins for early allergen introduction in infants versus standard practices advised by pediatricians. The goal is to see if these supplements make it easier for parents and reduce both healthcare costs and allergy rates.

2Treatment groups

Experimental Treatment

Active Control

Group I: InterventionExperimental Treatment1 Intervention

Participants randomized to the intervention group will receive an early allergen introduction supplement.

Group II: ControlActive Control1 Intervention

Participants randomized to the control group will follow the guidance of their pediatrician.