Human Breast Milk's Role in Food Allergy Development

Last updated: February 20, 2026
Sponsor: The University of Texas Medical Branch, Galveston
Overall Status: Trial Not Available

Phase

N/A

Condition

Allergy

Allergies & Asthma

Breast Feeding

Treatment

Early Introduction

Open Ended Oral Food Challenge

Clinical Study ID

NCT06765213
22-0307
  • Ages 4-24
  • All Genders
  • Accepts Healthy Volunteers

Study 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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Pregnant or post-partum females who plan to exclusively breastfeed and their infantswho have completed at least 37 weeks of gestation

  2. These are vulnerable populations

  3. Our study involves breastmilk analysis, which we need postpartum mothers tosupply.

  4. (Parent) Testing will be done solely on breastmilk samples, with only potentialdietary intervention done to the parent postpartum depending on the outcomes ofthe infant and breastmilk.

  5. (Infant) In order to determine if allergens in breastmilk play a role in foodallergen sensitization, we need to test the infants prior to the introductionof solid foods.

  6. Personal history of atopic disease such as allergic rhinitis/conjunctivitis, asthma,food allergies, and atopic dermatitis

  7. Maternal diet must include hen's egg, cow's milk, and wheat products.

Exclusion

Exclusion Criteria:

  1. No maternal history of atopic disease

  2. Exclusive formula feeding

  3. Maternal diet devoid of hen's egg, cow's milk, or wheat, for example, vegan dietsand persons with gluten sensitivity.

Study Design

Treatment Group(s): 2
Primary Treatment: Early Introduction
Phase:
Study Start date:
March 08, 2024
Estimated Completion Date:
February 19, 2026

Study 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.

Connect with a study center

  • Pediatric Sub Specialty Clinic at Bay Colony

    League City, Texas 77573
    United States

    Site Not Available

  • Pediatric Sub Specialty Clinic at Bay Colony

    League City 4705692, Texas 4736286 77573
    United States

    Site Not Available

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