Actively Recruiting

Phase Not Applicable
Age: 18Years - 40Years
FEMALE
Healthy Volunteers
NCT06260956

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

Led by University of Rochester · Updated on 2025-08-13

500

Participants Needed

1

Research Sites

213 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

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

Official Title

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

Who Can Participate

Age: 18Years - 40Years
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Able to understand and provide informed consent
  • English-speaking adults 18 years or older (Spanish speakers may be included if translation and support are available)
  • Maternal consent provided for infants
  • Pregnant women from confirmed pregnancy until 27 weeks gestation
  • No chronic inflammatory conditions needing long-term immunosuppressive medications in first or second trimester
  • Carrying a fetus with a first-degree relative having allergic disease (asthma, allergic rhinitis, atopic dermatitis, or food allergy)
  • Intend to breastfeed their infant exclusively for more than 3 months
  • Have eaten peanut and egg with no food allergy reactions
  • Willing to be randomized to either consume or avoid peanut and egg
  • Uncomplicated pregnancy (no gestational diabetes, preeclampsia, or hyperemesis gravidarum)
Not Eligible

You will not qualify if you...

  • Unable or unwilling to give written informed consent or comply with the study protocol
  • Known kidney, liver, or heart failure in mother or infant
  • Pregnant women with peanut or egg allergy
  • Pregnant women who refuse to eat peanut 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 risk to mother or infant or affecting study data quality, as determined by investigator

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University of Rochester

Rochester, New York, United States, 14642

Actively Recruiting

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Research Team

A

Allison W Leadley, MPH

CONTACT

L

Leanna Twohig, MS

CONTACT

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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