protocolSection identificationModule nctId: NCT06262867, orgStudyIdInfo id: ReadySetFood, briefTitle: Early Allergen System Experience, acronym: EASE, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-07, primaryCompletionDateStruct date: 2026-09-01, completionDateStruct date: 2026-09-01, studyFirstPostDateStruct date: 2024-02-16, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Prollergy dba Ready Set Food, class: OTHER, collaborators name: ObvioHealth, descriptionModule briefSummary: 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., conditionsModule conditions: Food Allergy in Infants, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 1110, type: ESTIMATED, armsInterventionsModule interventions name: Ready. Set. Food! Stage 1 Mix ins, outcomesModule primaryOutcomes measure: The proportion of caregivers who are adherent with the evidence-based guidance for cow's milk, egg, and peanut during the 6 - month period, secondaryOutcomes measure: Frequency of caregiver-reported allergy or food introduction-related adverse events (AEs) after introduction of cow's milk, egg, and peanut, secondaryOutcomes measure: Frequency of caregiver-reported serious adverse events (SAEs) after introduction of cow's milk, egg, and peanut, secondaryOutcomes measure: Frequency of caregiver-reported special interest adverse events (FPIES and anaphylaxis) after introduction to cow's milk, egg, and peanut by 12 months of age, otherOutcomes measure: The proportion of caregivers who are satisfied with introduction of egg, cow's milk, and peanut, otherOutcomes measure: The total allergy-related healthcare costs, otherOutcomes measure: The proportion of participants with food allergy to cow's milk, egg, or peanut, otherOutcomes measure: The proportion of participants with a suspected food allergy, eligibilityModule sex: ALL, minimumAge: 2 Months, maximumAge: 5 Months, stdAges: CHILD, contactsLocationsModule, hasResults: False