Expecting Mother's Study of Consumption or Avoidance of Peanut and Egg (ESCAPE)

Peanut allergy is the most common cause of fatal and near-fatal food-allergic reactions and egg allergy is among the two most common causes of food-induced anaphylaxis. The proposed research will explore the development of sensitization to these food(s) in infants based on maternal consumption or avoidance during pregnancy and breastfeeding.

Study Overview

• Status: Recruiting
• Conditions: Egg Allergy; Food Allergy Peanut; Food Allergy in Infants; Allergy and Immunology; Peanut and Nut Allergy
• Intervention / Treatment: Behavioral: Consumption; Behavioral: Avoidance

Detailed Description

The goals of this study include defining the role of egg and peanut consumption or avoidance during pregnancy and via human milk in food sensitization and identifying the underlying biological mechanisms leading to sensitization or tolerance. The study population will include 500 mother/infant dyads who plan to exclusively feed breastmilk to healthy infants. We expect approximately 25% will be recruited locally and the rest from across the United States. This is a national, parallel, two arm, one-to-one allocation, single blinded, randomized controlled trial. Each arm of the study defines maternal diet from 27 weeks gestation through their baby's fourth month with some consuming peanut and egg and some avoiding these foods.

• Study Type: Interventional
• Enrollment (Estimated): 500
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Allison W Leadley, MPH; Phone Number: 585-275-4640; Email: allison_leadley@urmc.rochester.edu
• Study Contact Backup: Name: Leanna Twohig, MS; Phone Number: 585-275-4640; Email: Leanna_Twohig@urmc.rochester.edu

Study Locations

• United States
  • New York
    • Rochester, New York, United States, 14642
      • Recruiting
      • University of Rochester
      • Principal Investigator: Kirsi Jarvinen-Seppo, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• o Subject must be able to understand and provide informed consent.

• English-speaking adults, 18 years or older. (Spanish speaking adults may be included after consent document is translated and Spanish speaking study representatives are available to conduct and answer questions during informed consent process and for study follow up.)
• Maternal consent must be provided for infants.
• Pregnant women from the time pregnancy is confirmed until 27 weeks of gestation.

• Self-reported at time of enrollment:

  • no chronic inflammatory conditions that require long-term systemic immunosuppressive medications in first or second trimester
  • carrying a fetus with a first-degree relative (i.e., mother, father, full sibling) with any self-reported or physician-diagnosed allergic disease (asthma, allergic rhinitis, atopic dermatitis, or food allergy).
• Intend to give their infant their own breast milk for more than 3 months.
• Can confidently say they have eaten PN and egg and have tolerated consumption with no food allergy reactions.
• Willing to be randomized to consumption or avoidance diet.
• Uncomplicated pregnancy (no gestational diabetes, no preeclampsia, no hyperemesis gravidarum), self-reported at time of enrollment.

Exclusion Criteria:

• Inability or unwillingness of subject to give written informed consent or comply with study protocol.
• Known history of renal/liver/cardiac insufficiency in the mother or infant.
• Pregnant women with PN or egg allergy.
• Pregnant women who refuse to eat PN (or peanut products) and/or eggs.
• Physician diagnosed immunodeficiency in the mother or infant.
• Current, diagnosed, mental illness or current, diagnosed, or self-reported, drug or alcohol abuse that, in the opinion of the investigator, would interfere with the subject's ability to comply with study requirements.
• Past or current medical problems or findings from medical history that are not listed above, which, in the opinion of the investigator, may pose additional risks to the mother or infant from participation in the study, may interfere with the subject's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Arm 1 Consumption; Subjects must consume peanuts and peanut products and egg and egg products.	Behavioral: Consumption; Subjects consume peanut and egg from 27 weeks of pregnancy through the first 4 months feeding breastmilk to their infant.
Active Comparator: Arm 2 Avoidance; Subjects must avoid eating peanuts and peanut products and egg and egg products.	Behavioral: Avoidance; Subjects avoid eating peanut and egg from 27 weeks of pregnancy through the first 4 months feeding breastmilk to their infant.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Egg or peanut sensitization	Determine the proportion of high-risk infants who have developed egg or peanut sensitization at four months (prior to introduction of these foods to the infant).	four months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peanut and egg specific IgG and IgG4	Levels of infant peanut and egg specific IgG and IgG4	four months
Egg allergy	Questionnaire for parents to report any signs of egg allergy in their child.	12 months
Egg and peanut specific IgE	Measure levels of infant egg- and peanut-specific IgE.	four months
Antibodies in maternal blood	Quantify egg- and PN-specific IgG and IgG4 antibody concentrations in maternal blood measured during pregnancy and at four months.	four months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exploratory: Peanut sensitization	The proportion of high-risk infants who have developed peanut sensitization	four months
Exploratory: Egg sensitization	Proportion of infants who develop egg sensitization.	four months
Exploratory: Symptoms	Questionnaire for parents to report symptoms of non-IgE mediated food allergy	four months
Exploratory: Peanut sensitization 12 months	Questionnaire for parents to report signs of peanut allergy	12 months
Mechanistic: antigen level	Measure PN and egg antigen levels in house dust and human milk	four months
Mechanistic: IgG levels	Quantify PN- and egg-specific IgG antibody levels in maternal serum and human milk.	four months
Mechanistic: T cell	Phenotype infant T cell populations in cord blood and infant blood.	four months

Collaborators and Investigators

• Sponsor: University of Rochester
• Collaborators: National Institute of Allergy and Infectious Diseases (NIAID)

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2025
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): September 1, 2029

Study Registration Dates

• First Submitted: February 7, 2024
• First Submitted That Met QC Criteria: February 7, 2024
• First Posted (Actual): February 15, 2024

Study Record Updates

• Last Update Posted (Actual): August 13, 2025
• Last Update Submitted That Met QC Criteria: August 8, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity, Immediate; Nut and Peanut Hypersensitivity; Hypersensitivity; Food Hypersensitivity; Peanut Hypersensitivity; Nut Hypersensitivity; Egg Hypersensitivity
• Other Study ID Numbers: U01-ROC-001; 1U01AI173032 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Per NIH policy

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No