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

Recruiting now · Not applicable

Conditions studied: Allergy and Immunology, Peanut and Nut Allergy, Egg Allergy, Food Allergy in Infants, Food Allergy Peanut

In brief

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.

Key facts

Study ID

NCT06260956

Run by

University of Rochester

People needed

500

Starts

2025-08-01

Expected to finish

2029-09-01

Last updated by the study team

2026-07-20

Who can join

Age: 0 and older. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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).

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.

Where it is running

• University of Rochester — Rochester, New York, United States (enrolling)

Full record on ClinicalTrials.gov

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