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

NCT06260956 | Recruiting DMC

• 2 other identifiers: U01-ROC-0011U01AI173032
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Allergy and Immunology; Peanut and Nut Allergy; Egg Allergy; Food Allergy in Infants; Food Allergy Peanut

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Peanut and egg specific IgG and IgG4

  four months

• Antibodies in maternal blood

  four months

• Egg allergy

  12 months

• Egg and peanut specific IgE

  four months

Other Outcomes (7)

• Exploratory: Peanut sensitization

  four months

• Exploratory: Egg sensitization

  four months

• Exploratory: Symptoms

  four months

Study Arms (2)

Arm 1 Consumption

ACTIVE COMPARATOR

Subjects must consume peanuts and peanut products and egg and egg products.

Behavioral: Consumption

Arm 2 Avoidance

ACTIVE COMPARATOR

Subjects must avoid eating peanuts and peanut products and egg and egg products.

Behavioral: Avoidance

Interventions

Consumption BEHAVIORAL

Subjects consume peanut and egg from 27 weeks of pregnancy through the first 4 months feeding breastmilk to their infant.

Arm 1 Consumption

Avoidance BEHAVIORAL

Subjects avoid eating peanut and egg from 27 weeks of pregnancy through the first 4 months feeding breastmilk to their infant.

Arm 2 Avoidance

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: To understand the mechanisms whereby maternal diet either positively or negatively affects the development of their infant from the womb through the first few months of life, it is necessary to recruit healthy pregnant women.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Rochester: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (1)

University of Rochester

Rochester, New York, 14642, United States

RECRUITING

MeSH Terms

Conditions

Hypersensitivity; Nut and Peanut Hypersensitivity; Egg Hypersensitivity; Peanut Hypersensitivity

Interventions

Economics; SAV4 protein, Arabidopsis

Condition Hierarchy (Ancestors)

Immune System Diseases; Food Hypersensitivity; Hypersensitivity, Immediate

Intervention Hierarchy (Ancestors)

Health Care Economics and Organizations

Central Study Contacts

Allison W Leadley, MPH

CONTACT

585-275-4640; allison_leadley@urmc.rochester.edu

Leanna Twohig, MS

CONTACT

585-275-4640; Leanna_Twohig@urmc.rochester.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Due to the nature of the intervention, the subjects must know which arm they are assigned to, however, biostatistician and investigators will be blinded to study assignment.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Pediatric Allergy and Immunology

Model Details: National, parallel, two arm (one-to-one allocation), single blinded, randomized controlled trial.

Study Record Dates

• First Submitted: February 7, 2024
• First Posted: February 15, 2024
• Study Start: August 1, 2025
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): September 1, 2029
• Last Updated: August 13, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share

Locations

US (1)