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

Part of paid clinical trials in Rochester, New York.

Sponsor
University of Rochester
Study ID
NCT06260956
Status
Recruiting
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Conditions

  • Allergy and Immunology
  • Egg Allergy
  • Food Allergy Peanut
  • Food Allergy in Infants
  • Peanut and Nut Allergy

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 40 Years
Healthy Volunteers
Accepted

Interventions

  • Consumption — BEHAVIORAL
    Subjects consume peanut and egg from 27 weeks of pregnancy through the first 4 months feeding breastmilk to their infant.
  • Avoidance — BEHAVIORAL
    Subjects avoid eating peanut and egg from 27 weeks of pregnancy through the first 4 months feeding breastmilk to their infant.

Study Details

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 Dates

Start date
Aug 1, 2025
Status verified
Aug 2025
Primary completion
Jun 30, 2028
Completion
Sep 30, 2029

Study Design

Enrollment
500 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

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.

Primary Outcome Measure

Egg or peanut sensitization [ Time Frame: four months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of RochesterRochesterNew York14642
Kirsi Jarvinen-Seppo, MD, PhD (PRINCIPAL_INVESTIGATOR)

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By research site
University of Rochester· Rochester, NY

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