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

Not Applicable

Not yet recruiting

• Conditions: Egg Allergy; Peanut and Nut Allergy; Allergy and Immunology; Food Allergy in Infants; Food Allergy Peanut
• Interventions: Behavioral: Consumption; Behavioral: Avoidance

• Registration Number: NCT06260956
• Lead Sponsor: University of Rochester

Brief 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.

Study Timeline

• Study First Submitted: 2024-02-07
• Study First Submitted QC: 2024-02-07
• Study First Posted: 2024-02-15
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-02
• Last Update Posted: 2025-04-04
• Study Start: 2025-06
• Primary Completion: 2028-06
• Study Completion: 2029-09

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 500

Inclusion Criteria

• 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.
• Self-reported at time of enrollment: pregnant female with 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).
• Intention to give their infant their own breast milk for more than 3 months.
• Mothers who 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.

Exclusion Criteria

• Inability or unwillingness of subject to give written informed consent or comply with study protocol.
• Known history of renal/liver/cardiac insufficiency in the mother or infant.
• Pregnant women with PN or egg allergy.
• Pregnant women who refuse to eat PN (or peanut products) and/or eggs.
• Physician diagnosed immunodeficiency in the mother or infant.
• Current, diagnosed, mental illness or current, diagnosed, or self-reported, drug or alcohol abuse that, in the opinion of the investigator, would interfere with the subject's ability to comply with study requirements.
• Past or current medical problems or findings from medical history that are not listed above, which, in the opinion of the investigator, may pose additional risks to the mother or infant from participation in the study, may interfere with the subject's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 2 Consumption	Consumption	Subjects must consume peanuts and peanut products and egg and egg products.
Arm 1 Avoidance	Avoidance	Subjects must avoid eating peanuts and peanut products and egg and egg products.

Primary Outcome Measures

Name	Time	Method
Egg or peanut sensitization	four months	Determine the proportion of high-risk infants who have developed egg or peanut sensitization at four months (prior to introduction of these foods to the infant).

Secondary Outcome Measures

Name	Time	Method
Peanut and egg specific IgG and IgG4	four months	Levels of infant peanut and egg specific IgG and IgG4
Antibodies in maternal blood	four months	Quantify egg- and PN-specific IgG and IgG4 antibody concentrations in maternal blood measured during pregnancy (ROC only) and at four months.
Egg allergy	12 months	Questionnaire for parents to report any signs of egg allergy in their child.
Egg and peanut specific IgE	four months	Measure levels of infant egg- and peanut-specific IgE.

Trial Locations

Locations (1)

University of Rochester; 🇺🇸 Rochester, New York, United States