Early Allergen System Experience

NCT06262867 | Active Not Recruiting

• 1 other identifier: ReadySetFood
• Study Type: interventional
• Target: 1,110
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Food Allergy in Infants

Outcome Measures

Primary Outcomes (1)

• The proportion of caregivers who are adherent with the evidence-based guidance for cow's milk, egg, and peanut during the 6 - month period

  Adherence will be measured using a food frequency questionnaire

  6 months of intervention

Secondary Outcomes (3)

• Frequency of caregiver-reported allergy or food introduction-related adverse events (AEs) after introduction of cow's milk, egg, and peanut

  12 months of age

• Frequency of caregiver-reported serious adverse events (SAEs) after introduction of cow's milk, egg, and peanut

  12 months of age

• 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

  12 months of age

Other Outcomes (4)

• The proportion of caregivers who are satisfied with introduction of egg, cow's milk, and peanut

  12 months of age

• The total allergy-related healthcare costs

  24 months of age

• The proportion of participants with food allergy to cow's milk, egg, or peanut

  24 months of age

Study Arms (2)

Intervention

EXPERIMENTAL

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

Dietary Supplement: Ready. Set. Food! Stage 1 Mix ins

Control

NO INTERVENTION

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

Interventions

Ready. Set. Food! Stage 1 Mix ins DIETARY_SUPPLEMENT

These supplements contain cow's milk, eggs, and peanuts.

Also known as: Ready. Set. Food! Stage 2 Mix ins

Intervention

Eligibility Criteria

• Age: 2 Months - 5 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Full term, singleton birth
• Infant will be 2-5 months old at the time of study enrollment
• Able to participate in the study under the supervision of a caregiver or legal guardian -who must be:
• At least 18 years of age
• The caregiver or legal guardian of the infant
• Living with the infant for the duration of the study
• Willing to follow all caregiver responsibilities
• Willing and able to sign the electronic Informed Consent
• Willing to conform to all protocol requirements (e.g., completion of study questionnaires and procedures, and reporting of AEs)
• Caregiver or legal guardian who owns a functioning smartphone device, has access to an internet connection (Wi-Fi or data plan), and is willing to download the study app

You may not qualify if:

• Known sensitivity/allergy to egg, cow's milk, or peanut (including products containing egg, cow's milk, or peanut) or undergoing evaluation for reactions due to cow's milk, egg, or peanut exposure (including exposure to products containing egg, cow's milk, or peanut).
• Participating in a clinical trial and/or treated with any investigational product within 3 months preceding the first dose of study product.
• Clinically significant medical conditions such as cardiac disease or lung disease, and/or babies who have bloody stools that have required milk elimination that are unstable or uncontrolled and may interfere with a participant's participation in the study in the opinion of the medically qualified investigator.
• Other severe, acute or chronic, medical or psychiatric condition(s) or laboratory abnormality(ies) that may increase the risk associated with study participation or intervention product administration or may interfere with the interpretation of study results, and in the judgment of the medically qualified investigator, would make the participant inappropriate for entry into this study.
• Preterm delivery (\<37 weeks \[259 days\] gestational age).
• Admission to the neonatal unit ≥ 3 days for issues other than establishment of normal feeding.
• Chronic use of antibiotics (≥ 28 consecutive days)
• Evidence of a baseline illness that would, in the opinion of the PI, introduce a significant safety concern if the infant is enrolled in the study or otherwise preclude study participation.
• Significant birth defect/complication that would, in the opinion of the PI, create a safety concern or otherwise confound the study (e.g., abdominal wall defects, congenital heart disease).
• Medical condition (infant) that, in the opinion of the PI, may significantly alter gut microbiota or healthy immune responses.
• Maternal infection with human immunodeficiency virus, tuberculosis, hepatitis C, or hepatitis B.
• Caregiver condition that, in the opinion of the PI, would not allow the Caregiver and/or infant to comply with the study protocol requirements.
• History of immunocompromised conditions. Is related to persons involved directly or indirectly with the conduct of this study (i.e., PI, sub-investigators, study coordinators, other study personnel, employees of Ready. Set. Food! contractors of Ready. Set. Food! and the families of each).

Sponsors & Collaborators

• Prollergy dba Ready Set Food: lead
• ObvioHealth: collaborator

Study Sites (1)

Virtual Site Location - Curavit

New York, New York, 10583, United States

Location

Study Officials

• Kara McNamara, MD

  ObvioHealth

  PRINCIPAL INVESTIGATOR

• Vikram Garg, MD

  Curavit

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2024
• First Posted: February 16, 2024
• Study Start: March 7, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: June 5, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)