Ignite Creation Date:
2024-05-06 @ 8:07 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06262867
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-20
First Post:
2024-01-26
Brief Title:
Early Allergen System Experience
Sponsor:
Prollergy dba Ready Set Food
Organization:
Prollergy dba Ready Set Food
Study Overview
Official Title:
Pragmatic Randomized Controlled Trial of Early Cows Milk Egg and Peanut Allergen Introduction and Maintenance in Healthy and High-Risk Infants
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EASE
Brief Summary:
Multiple clinical trials have demonstrated that early allergen introduction feeding babies common food allergens before six months decreases childrens 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 cows 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 200000 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 1100 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
This study investigates the effectiveness of introducing common allergens to infants with the goal of preventing food allergies The study will enroll 1100 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
Detailed 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 cows milk hens egg peanuts tree nuts wheat soy and sesame The prevalence of food allergy has surged affecting 8 of United States US 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 cows 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 cows milk formula reduced cows 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 US 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 cows 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 150000 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
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 cows milk formula reduced cows 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 US 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 cows 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 150000 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None