Recruiting

Observational Study

Sponsor:

University of Rochester

Code:

NCT06260956

Conditions

Allergy and Immunology

Peanut and Nut Allergy

Egg Allergy

Food Allergy in Infants

Food Allergy Peanut

Eligibility Criteria

Sex: Female

Age: 0+

Healthy Volunteers: Accepted

Interventions

Consumption

Avoidance

Study Details

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

Study ID

NCT06260956

Start date

Aug 1, 2025

Status verified date

Aug, 2025

Completion date

Sep, 2029

Anticipated

Primary completion date

Jun, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 0+

Healthy Volunteers: Accepted

Inclusion Criteria:

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

  • Mothers will be 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.

Infants will be minimum age, 1 day (birth), through 365 days (12 months).

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 Design

Enrollment

500 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

active comparator: Arm 1 Consumption

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

active comparator: Arm 2 Avoidance

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

Interventions

Consumption

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

Avoidance

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

Primary outcome measure

  • Egg or peanut sensitization [ Time Frame: four months ]

Central Contacts and Locations

Central contacts

Allison W Leadley, MPH

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

Elizabeth Catlin

585-895-3911elizabeth_catlin@urmc.rochester.edu

Locations

University of Rochester

Recruiting

Rochester, New York, United States, 14642

Principal Investigator:

Kirsi Jarvinen-Seppo, MD, PhD

More Information

Sponsor

University of Rochester

Last update posted

Jul 20, 2026

Last verified

Aug, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Rochester on 2026-07-20.