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

Last updated: August 8, 2025
Sponsor: University of Rochester
Overall Status: Active - Recruiting

Phase

N/A

Condition

Allergy (Peanut)

Allergies & Asthma

Allergy

Treatment

Avoidance

Consumption

Clinical Study ID

NCT06260956
U01-ROC-001
1U01AI173032
  • Ages 18-40
  • Female
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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 includedafter consent document is translated and Spanish speaking study representatives areavailable to conduct and answer questions during informed consent process and forstudy 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 systemicimmunosuppressive medications in first or second trimester

  • carrying a fetus with a first-degree relative (i.e., mother, father, fullsibling) 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 withno food allergy reactions.

  • Willing to be randomized to consumption or avoidance diet.

  • Uncomplicated pregnancy (no gestational diabetes, no preeclampsia, no hyperemesisgravidarum), self-reported at time of enrollment.

Exclusion

Exclusion Criteria:

  • Inability or unwillingness of subject to give written informed consent or complywith 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 oralcohol abuse that, in the opinion of the investigator, would interfere with thesubject's ability to comply with study requirements.

  • Past or current medical problems or findings from medical history that are notlisted above, which, in the opinion of the investigator, may pose additional risksto the mother or infant from participation in the study, may interfere with thesubject's ability to comply with study requirements or that may impact the qualityor interpretation of the data obtained from the study.

Study Design

Total Participants: 500
Treatment Group(s): 2
Primary Treatment: Avoidance
Phase:
Study Start date:
August 01, 2025
Estimated Completion Date:
September 30, 2029

Study 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.

Connect with a study center

  • University of Rochester

    Rochester, New York 14642
    United States

    Active - Recruiting

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