NCT06765213

Human Breast Milk's Role in Food Allergy Development

Evaluation of Human Breast Milk and Its Role in Early Food Allergen Sensitization in Infants

• Status: Withdrawn
• Phase: —
• Study type: Observational
• Enrollment: 0 (actual)
• Sponsor: The University of Texas Medical Branch, Galveston · Academic / Other
• Sex: All
• Age: 4 Months – 24 Months
• Healthy volunteers: Accepted

Summary

The goal of this prospective cohort pilot study is to learn about food allergens being passed on in breast milk to breast feeding infants. The main question\[s\] it aims to answer are: * Will major allergens for milk, egg, and peanut be passed on to infants in breast milk? * Will the infants become sensitized to and develop an allergy to the food allergens found in breast milk? * Will early introduction interventions prevent the development of these food allergies? Participants will * provide breast milk sample (s) for testing for food allergens * Infants will be tested for sensitization via skin prick and blood testing * Infants will be challenge with suspected foods to determine allergy and undergo early introduction procedures

Detailed description

Recruitment of subjects will be open enrollment pregnant or post-partum women with a personal history of atopic disease such as allergic rhinitis/conjunctivitis, asthma, atopic dermatitis (eczema), and/or food allergy who are exclusively breastfeeding. Mothers will provide a breastmilk sample(s) for testing of allergens to milk, egg, and wheat. Prior to the introduction of solid foods, infants will need to be tested for sensitization to milk, egg, and wheat via skin prick testing and blood allergy testing. Infants that are negative for sensitization will undergo introduction of these foods per standard practice. Infants that are positive for sensitization will undergo an office food challenge for those foods that they are sensitized to. A positive food challenge is diagnostic for a food allergy and they will be managed according to standard practice. A negative food challenge means that they are not allergic, and they will undergo early introduction protocols and monitored to continued tolerance.

Conditions

• Food Allergy in Infants
• Food Allergen Sensitisation
• Breast Feeding, Exclusive
• Breastmilk Collection

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Open Ended Oral Food Challenge	Allergens determined to be sensitized will be brought in for an oral challenge to that food.
OTHER	Early Introduction	Infants that are not sensitized will have the food introduced to their diet at regular intervals.

Timeline

• Start date: 2024-03-08
• Primary completion: 2026-02-19
• Completion: 2026-02-19
• First posted: 2025-01-09
• Last updated: 2026-02-24