Recruiting

Observational Study

Sponsor:

The University of Texas Medical Branch, Galveston

Code:

NCT06765213

Conditions

Food Allergy in Infants

Food Allergen Sensitisation

Breast Feeding, Exclusive

Breastmilk Collection

Eligibility Criteria

Sex: All

Age: 0 - 2

Healthy Volunteers: Accepted

Interventions

Open Ended Oral Food Challenge

Early Introduction

Study Details

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

Study ID

NCT06765213

Start date

Mar 8, 2024

Status verified date

Oct, 2025

Completion date

Dec, 2026

Anticipated

Primary completion date

Jun, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 2

Healthy Volunteers: Accepted

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 Design

Enrollment

20 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

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.

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.

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.

Interventions

Open Ended Oral Food Challenge

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

Early Introduction

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

Primary outcome measure

  • To assess the detection of allergens in human breast milk [ Time Frame: Baseline (4 months of age) ]
  • To assess breast milk's role in sensitization to allergens [ Time Frame: Baseline (4 months of age) ]

Central Contacts and Locations

Central contacts

Cleavon Covington, MD

409-772-0433clcoving@utmb.edu

Joanne Acevedo, MD

jgaceved@utmb.edu

Locations

Pediatric Sub Specialty Clinic at Bay Colony

Recruiting

League City, Texas, United States, 77573

More Information

Sponsor

The University of Texas Medical Branch, Galveston

Last update posted

Oct 14, 2025

Last verified

Oct, 2025

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-10. This information was provided to ClinicalTrials.gov by The University of Texas Medical Branch, Galveston on 2025-10-14. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.