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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 40
Healthy Volunteers: t
View:

∙ • o Subject must be able to understand and provide informed consent.

• 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.

Locations
United States
New York
University of Rochester
RECRUITING
Rochester
Contact Information
Primary
Allison W Leadley, MPH
allison_leadley@urmc.rochester.edu
585-275-4640
Backup
Leanna Twohig, MS
Leanna_Twohig@urmc.rochester.edu
585-275-4640
Time Frame
Start Date: 2025-08-01
Estimated Completion Date: 2029-09
Participants
Target number of participants: 500
Treatments
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.
Related Therapeutic Areas
Sponsors
Collaborators: National Institute of Allergy and Infectious Diseases (NIAID)
Leads: University of Rochester

This content was sourced from clinicaltrials.gov