Human Breast Milk's Role in Food Allergy Development

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

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

Study Overview

• Status: Withdrawn
• Conditions: Breast Feeding, Exclusive; Food Allergy in Infants; Food Allergen Sensitisation; Breastmilk Collection
• Intervention / Treatment: Diagnostic test: Open Ended Oral Food Challenge; Other: Early Introduction

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.

• Study Type: Observational

Contacts and Locations

Study Locations

• United States
  • Texas
    • League City, Texas, United States, 77573
      • Recruiting
      • Pediatric Sub Specialty Clinic at Bay Colony
      • Contact: Cleavon Covington, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

Infants at 4 months of age up to 24 months of age.

Description

Inclusion Criteria:

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

   1. These are vulnerable populations
   2. Our study involves breastmilk analysis, which we need postpartum mothers to supply.
   3. (Parent) Testing will be done solely on breastmilk samples, with only potential dietary intervention done to the parent postpartum depending on the outcomes of the infant and breastmilk.
   4. (Infant) In order to determine if allergens in breastmilk play a role in food allergen sensitization, we need to test the infants prior to the introduction of solid foods.
2. Personal history of atopic disease such as allergic rhinitis/conjunctivitis, asthma, food allergies, and atopic dermatitis
3. Maternal diet must include hen's egg, cow's milk, and wheat products.

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 diets and persons with gluten sensitivity.

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Breastmilk positive/Infant sensitized; This group is for infants whose mother's breastmilk is found to be positive for allergens to either cow milk, egg, and/or wheat and who are found to be sensitized to one or more of these allergens.	Diagnostic test: Open Ended Oral Food Challenge; Allergens determined to be sensitized will be brought in for an oral challenge to that food.
Breastmilk positive/Infant not sensitized; This group is for infants whose mother's breastmilk is found to be positive for allergens to either cow milk, egg, and/or wheat and who are found to be not sensitized to the three allergens.	Other: Early Introduction; Infants that are not sensitized will have the food introduced to their diet at regular intervals.
Breastmilk negative/Infant sensitized; This group is for infants whose mother's breastmilk is found to be negative for allergens to either cow milk, egg, and/or wheat and who are found to be sensitized to one or more of these allergens.	Diagnostic test: Open Ended Oral Food Challenge; Allergens determined to be sensitized will be brought in for an oral challenge to that food.
Breastmilk negative/Infant not sensitized; This group is for infants whose mother's breastmilk is found to be negative for allergens to either cow milk, egg, and/or wheat and who are found to be not sensitized to the three allergens.	Other: Early Introduction; Infants that are not sensitized will have the food introduced to their diet at regular intervals.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To assess the detection of allergens in human breast milk	A mass spectrometry will be used to detect the allergens. Mass spectrometry is a technique used in the University of Texas Medical Branch (UTMB) laboratory to detect allergens.	Baseline (4 months of age)
To assess breast milk's role in sensitization to allergens	The infant will be skin prick tested for allergens to milk, eggs, and wheat at 4 months, which is the baseline.	Baseline (4 months of age)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of non-sensitized participants	The infants that are non-sensitized will begin consuming milk, eggs, and wheat, and each well child check visit.	Baseline (4 months of age), 12 months of age, 24 months of age

Collaborators and Investigators

• Sponsor: The University of Texas Medical Branch, Galveston
• Collaborators: Texas Allergy, Asthma, and Immunology Society

Study record dates

Study Major Dates

• Study Start (Actual): March 8, 2024
• Primary Completion (Actual): February 19, 2026
• Study Completion (Actual): February 19, 2026

Study Registration Dates

• First Submitted: December 23, 2024
• First Submitted That Met QC Criteria: January 2, 2025
• First Posted (Actual): January 9, 2025

Study Record Updates

• Last Update Posted (Actual): February 24, 2026
• Last Update Submitted That Met QC Criteria: February 20, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: food allergy; egg allergy; cow milk allergy; wheat allergy; breastmilk allergen testing; food allergen sensitization
• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity, Immediate; Hypersensitivity; Behavior; Feeding Behavior; Food Hypersensitivity; Milk Hypersensitivity; Egg Hypersensitivity; Wheat Hypersensitivity; Breast Feeding; Breast Milk Expression
• Other Study ID Numbers: 22-0307

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No