NCT06260956

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 500 (estimated)
• Sponsor: University of Rochester · Academic / Other
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

The goals of this study include defining the role of egg and peanut consumption or avoidance during pregnancy and via human milk in food sensitization and identifying the underlying biological mechanisms leading to sensitization or tolerance. The study population will include 500 mother/infant dyads who plan to exclusively feed breastmilk to healthy infants. We expect approximately 25% will be recruited locally and the rest from across the United States. This is a national, parallel, two arm, one-to-one allocation, single blinded, randomized controlled trial. Each arm of the study defines maternal diet from 27 weeks gestation through their baby's fourth month with some consuming peanut and egg and some avoiding these foods.

Conditions

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

Interventions

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

Timeline

• Start date: 2025-08-01
• Primary completion: 2028-06-01
• Completion: 2029-09-01
• First posted: 2024-02-15
• Last updated: 2025-08-13

Locations

1 site across 1 country: United States