Expecting Mother's Study of Consumption or Avoidance of Peanut and Egg
University of Rochester · with National Institute of Allergy and Infectious Diseases (NIAID) · NCT06260956
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 0 mo+ · Women only
- Healthy volunteers
- Accepted
- Study type
- Interventional · Not applicable
- Target enrollment
- 500
- US sites recruiting
- 1
- Study start
- August 1, 2025
- Record last updated
- October 8, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
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.
Being studied: Consumption; Avoidance
Conditions: Allergy and Immunology; Peanut and Nut Allergy; Egg Allergy; Food Allergy in Infants; Food Allergy Peanut
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full criteria
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.
Recruiting US locations
University of Rochester
Rochester, NY 14642
Site contact: Kirsi Jarvinen-Seppo, MD, PhD
Study contacts (from the official record)
- Allison W Leadley, MPH · 585-275-4640 · allison_leadley@urmc.rochester.edu
- Elizabeth Catlin · 585-895-3911 · elizabeth_catlin@urmc.rochester.edu
Similar studies in New York
All healthy volunteers studies in New York →- RecruitingHealthy volunteers
Using Middle School Science Teachers to Address Cancer Health Disparities
Weill Medical College of Cornell University
- Location
- New York, NY + 1 other US site
- Eligibility basics
- Ages 10+
- RecruitingHealthy volunteersPhase 1/Phase 2
A Phase I/II Study of ITU512 in Healthy Participants and Patients With Sickle Cell Disease
Novartis Pharmaceuticals
- Location
- New York, NY + 7 other US sites
- Eligibility basics
- Ages 12–55
- RecruitingHealthy volunteersPhase 1/Phase 2
Phase 1/2 Study of Respiratory Syncytial Virus and Human Metapneumovirus (RSV+HMPV) Vaccine Candidate in Adults 60 Years of Age and Older
Sanofi
- Location
- Staten Island, NY + 49 other US sites
- Eligibility basics
- Ages 60+
- RecruitingHealthy volunteersPhase 1
A Clinical Study of Novel Pneumococcal Vaccine V118C in Children (V118C-002)
Merck Sharp & Dohme LLC
- Location
- East Syracuse, NY + 14 other US sites
- Eligibility basics
- Ages 2 mo–1