Clinical trial NCT06765213: Human Breast Milk's Role in Food Allergy Development
Official title: Evaluation of Human Breast Milk and Its Role in Early Food Allergen Sensitization in Infants
Study type: OBSERVATIONAL
Overall status: RECRUITING
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
Lead sponsor: The University of Texas Medical Branch, Galveston
Sponsor class: OTHER
Collaborators: name: Texas Allergy, Asthma, and Immunology Society
First posted: 2025-01-09
Enrollment: 20
Sex: ALL
Minimum age (years): 4
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Infants at 4 months of age up to 24 months of age.

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.

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.

Primary outcomes:
measure: To assess the detection of allergens in human breast milk
timeFrame: Baseline (4 months of age)
measure: To assess breast milk's role in sensitization to allergens
timeFrame: Baseline (4 months of age)
Secondary outcomes:
measure: Number of non-sensitized participants
timeFrame: Baseline (4 months of age), 12 months of age, 24 months of age
Other outcomes:
Locations:
city: League City
country: United States
facility: Pediatric Sub Specialty Clinic at Bay Colony
state: Texas
Study officials:
References: