Human Breast Milk's Role in Food Allergy Development

NCT06765213 | Withdrawn DMC

• 1 other identifier: 22-0307
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Conditions

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

Keywords

food allergy; breastmilk allergen testing; food allergen sensitization; cow milk allergy; egg allergy; wheat allergy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Number of non-sensitized participants

  Baseline (4 months of age), 12 months of age, 24 months of age

Study Arms (4)

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

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

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

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

Interventions

Open Ended Oral Food Challenge DIAGNOSTIC_TEST

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

Breastmilk negative/Infant sensitized; Breastmilk positive/Infant sensitized

Early Introduction OTHER

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

Breastmilk negative/Infant not sensitized; Breastmilk positive/Infant not sensitized

Eligibility Criteria

• Age: 4 Months - 24 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• Pregnant or post-partum females who plan to exclusively breastfeed and their infants who have completed at least 37 weeks of gestation
• These are vulnerable populations
• Our study involves breastmilk analysis, which we need postpartum mothers to supply.
• (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.
• (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.
• Personal history of atopic disease such as allergic rhinitis/conjunctivitis, asthma, food allergies, and atopic dermatitis
• Maternal diet must include hen's egg, cow's milk, and wheat products.

You may not qualify if:

• No maternal history of atopic disease
• Exclusive formula feeding
• Maternal diet devoid of hen's egg, cow's milk, or wheat, for example, vegan diets and persons with gluten sensitivity.

Sponsors & Collaborators

• The University of Texas Medical Branch, Galveston: lead
• Texas Allergy, Asthma, and Immunology Society: collaborator

MeSH Terms

Conditions

Breast Feeding; Breast Milk Expression; Food Hypersensitivity; Milk Hypersensitivity; Egg Hypersensitivity; Wheat Hypersensitivity

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 23, 2024
• First Posted: January 9, 2025
• Study Start: March 8, 2024
• Primary Completion: February 19, 2026
• Study Completion: February 19, 2026
• Last Updated: February 24, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)