Human Breast Milk's Role in Food Allergy Development

NCT ID: NCT06765213

Last Updated: 2025-10-14

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-03-08
• Study Completion Date: 2026-12-31

Brief 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Open Ended Oral Food Challenge

Intervention Type: DIAGNOSTIC_TEST

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.

Early Introduction

Intervention Type: OTHER

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.

Open Ended Oral Food Challenge

Intervention Type: DIAGNOSTIC_TEST

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.

Early Introduction

Intervention Type: OTHER

Infants that are not sensitized will have the food introduced to their diet at regular intervals.

Interventions

Open Ended Oral Food Challenge

Allergens determined to be sensitized will be brought in for an oral challenge to that food.

Intervention Type: DIAGNOSTIC_TEST

Early Introduction

Infants that are not sensitized will have the food introduced to their diet at regular intervals.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 4 Months
• Maximum Eligible Age: 24 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Texas Allergy, Asthma, and Immunology Society

UNKNOWN

Sponsor Role: collaborator

The University of Texas Medical Branch, Galveston

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Pediatric Sub Specialty Clinic at Bay Colony

League City, Texas, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Cleavon Covington, MD

Role: CONTACT

clcoving@utmb.edu

409-772-0433

Joanne Acevedo, MD

Role: CONTACT

jgaceved@utmb.edu

Facility Contacts

Cleavon Covington, MD

Role: primary

Other Identifiers

22-0307

Identifier Type: -

Identifier Source: org_study_id