Actively Recruiting
Expecting Mother's Study of Consumption or Avoidance of Peanut and Egg to Explore Infant Food Sensitization
Led by University of Rochester · Updated on 2025-08-13
500
Participants Needed
1
Research Sites
65 weeks
Total Duration
On this page
Sponsors
U
University of Rochester
Lead Sponsor
N
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to understand how consuming or avoiding peanut and egg during pregnancy and breastfeeding affects food sensitization in infants. The study focuses on mothers and their healthy infants, exploring the biological mechanisms behind developing sensitivity or tolerance to these common allergenic foods. This is a national randomized controlled trial involving 500 mother-infant pairs, with about 25% recruited locally and the rest across the United States. Participants are divided into two groups: one group will consume peanuts and eggs from 27 weeks of pregnancy through the baby's first four months of breastfeeding, while the other group will avoid these foods during the same period. This trial is single-blinded and designed to compare the effects of maternal diet on infant food sensitization. Mothers and infants will be closely monitored with measurements including food sensitization at four months, specific antibodies in both infant and maternal blood, and egg allergy assessment at 12 months. The study tracks immune responses such as peanut and egg specific IgE, IgG, and IgG4 antibodies. Participant involvement includes providing breast milk feeding data and attending scheduled assessments through the first year of the infant's life.
CONDITIONS
Brief Title
Expecting Mother's Study of Consumption or Avoidance of Peanut and Egg
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to understand and provide informed consent
- English-speaking adults aged 18 years or older (Spanish speakers may be included with appropriate support)
- Maternal consent provided for infants
- Pregnant women confirmed and less than 27 weeks gestation
- No chronic inflammatory conditions requiring long-term systemic immunosuppressive medications in first or second trimester
- Carrying a fetus with a first-degree relative with allergic disease (asthma, allergic rhinitis, atopic dermatitis, or food allergy)
- Plan to exclusively breastfeed infant for more than 3 months
- Have eaten peanuts and eggs without allergic reactions
- Willing to be randomized to consume or avoid peanuts and eggs
- Uncomplicated pregnancy (no gestational diabetes, preeclampsia, or hyperemesis gravidarum)
You will not qualify if you...
- Unable or unwilling to provide written informed consent or comply with study protocol
- Known renal, liver, or cardiac insufficiency in mother or infant
- Pregnant women with peanut or egg allergy
- Pregnant women who refuse to eat peanuts and/or eggs
- Physician-diagnosed immunodeficiency in mother or infant
- Current diagnosed mental illness or drug/alcohol abuse interfering with study compliance
- Past or current medical problems posing additional risks or interfering with study requirements or data quality as judged by investigator
- Noncompliance with study requirements or inability to complete study procedures as assessed by investigator
- Non-English or Spanish speakers without appropriate support for consent and follow-up if applicable
- Complicated pregnancy conditions excluded (gestational diabetes, preeclampsia, hyperemesis gravidarum) if reported at enrollment
- Allergy or intolerance to peanuts or eggs
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - From 27 weeks of pregnancy through 4 months postpartum
Participants follow a dietary plan to either consume or avoid peanuts and eggs from 27 weeks of pregnancy through their baby’s first 4 months of exclusive breastfeeding.
Regular dietary adherence with scheduled check-ins
Duration - Up to 12 months after birth
Participants and their infants are observed for food sensitization and antibody levels up to 12 months after birth.
Follow-up visits at 4 and 12 months postpartum
Trial Site Locations
Total: 1 location
1
University of Rochester
Rochester, New York, United States, 14642
Actively Recruiting
Research Team
A
Allison W Leadley, MPH
L
Leanna Twohig, MS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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