Early Allergen System Experience — EASE  

Food Allergy in Infants Clinical Trial

Official title: Pragmatic, Randomized, Controlled Trial of Early Cow's Milk, Egg, and Peanut Allergen Introduction and Maintenance in Healthy and High-Risk Infants

Status Not yet recruiting

Clinical Trial 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.

Clinical Trial Description

Childhood food allergy is characterized by the loss of immune tolerance to specific foods, triggering immune reactions that manifest in various symptoms, including skin, respiratory, gastrointestinal, and cardiovascular issues. Common triggers in children include proteins from cow's milk, hen's egg, peanuts, tree nuts, wheat, soy, and sesame. The prevalence of food allergy has surged, affecting 8% of United States (U.S.) children, with a notable increase in food-induced anaphylactic reactions. Peanut allergy, in particular, tends to be persistent, with a lower resolution rate than egg and cow's milk allergy. Milk and egg allergies are more likely to resolve, but make up the bulk of food allergies in infants and young toddlers and are associated with nutritional deficiencies and growth restriction.

Several randomized, controlled trials have investigated early allergen introduction to prevent food allergy. The Learning Early About Peanut (LEAP) study demonstrated a significant reduction in peanut allergy by introducing peanuts early, irrespective of baseline sensitization. Follow-up indicated sustained risk reduction. The Enquiring About Tolerance (EAT) trial explored the early introduction of multiple allergens, showing a lower relative risk of food allergy, particularly peanut and egg allergy in infants who were regularly fed the allergens. The Prevention of Egg Allergy in High-Risk Infants with Eczema (PETIT) study focused on egg introduction, revealing a preventive effect with gradual, consistent consumption. The Strategy for Prevention of Milk Allergy by Daily Ingestion of Infant Formula in Early Infancy (SPADE) study highlighted that early ingestion of cow's milk formula reduced cow's milk allergy risk. Early Food Intervention and Skin Emollients to Prevent Food Allergy in Young Children (PreventADALL), a multicenter trial, combined skin and food interventions, demonstrating a reduced food allergy at 36 months. Government bodies and professional societies, including National Institute of Allergy and Infectious Disease (NIAID), American Academy of Pediatrics (AAP), American Academy of Allergy, Asthma, and Immunology (AAAAI), American College of Allergy, Asthma, and Immunology (ACAAI), and Canadian Society of Allergy and Clinical Immunology (CSACI), recommend early allergen introduction based on these trials.

Guidelines advise introducing peanut and other allergenic foods by 6 months, avoiding delays, especially for high-risk infants with severe eczema or egg allergy. The PreventADALL trial supported early exposure to allergenic foods to prevent food allergy. The Center for Disease Control (CDC) reported varying ages of complementary food introduction in the U.S., with a prevalence of early introduction before 4 months. Despite guidelines, low adherence rates were observed in the PreventADALL trial.

Safety of Introducing Food to Infants:

Infant anaphylaxis is rare, with allergic infants typically presenting with mild to moderate symptoms. Clinical trials and real-world studies demonstrated low rates of severe reactions, even in higher-risk infants. Recent guidelines focus on early, regular allergen ingestion, emphasizing the safety of introducing potentially allergenic foods to infants.

Study Rationale:

The trials promoting early allergen introduction face challenges in widespread adoption due to the difficulty of maintaining feeding requirements. In the case of LEAP, parents were contacted 104 times throughout the study to ensure compliance. For the EAT study, only 43% of parents could maintain the feeding requirements, which included large amounts of solid foods for infants who had not started eating otherwise, and some had difficulties doing so. Consumption levels were a critical factor for the EAT study: the reduction in food allergy was only shown to be statistically significant in the group of families who could maintain a certain level of compliance. The data from LEAP and EAT indicate that ingestion of 2 grams of protein per week of the allergenic food was required to decrease the risk of food allergy. Ingesting 2 grams of protein per week of allergenic food is crucial. Early introduction, before 6 months, is vital, but a method for infants not developmentally ready for solids is needed.

Ready. Set. Food! Stage 1 and 2 Mix-ins address these challenges with a patented direct-to-consumer product introducing top pediatric allergens in stages. It covers cow's milk, egg, and peanut, representing over 80% of childhood food allergies. The regimen, dissolved in a bottle of breast milk or formula, follows a sequential introduction process, replicating home food introduction. The formulation aims to promote tolerance development via the gastrointestinal system, aligning with prevention trials. Over 150,000 infants have used Ready. Set. Food! and in preliminary assessments of consumers, more than 95% achieved the clinically recommended duration with very few allergic reactions.

The study design was created to mimic the real-world environment in which caregivers would introduce allergens to their infants. Therefore, the study design avoids in-person visits with the study team and prescriptive requirements for testing and evaluation. Due to the nature of the study, blinding the interventional group would not replicate a real-world environment. In addition, an unblinded study allows caregivers to seek additional information and support, such as they would in a real-world environment, and make decisions based on the early allergen introduction they have completed. ;

Related Conditions & MeSH terms

• Food Allergy in Infants
• Food Hypersensitivity

• NCT number: NCT06262867
• Study type: Interventional
• Source: Prollergy dba Ready Set Food
• Contact: Parth Shah, MD
• Phone: 1-888-209--6654
• Email: ease@obviohealth.com
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 7, 2024
• Completion date: September 1, 2026