Human Breast Milk's Role in Food Allergy Development

The University of Texas System (UT)

Status: Enrolling

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

Treatments: Other: Early Introduction; Diagnostic Test: Open Ended Oral Food Challenge

Study type: Observational

Funder types: Other

Identifiers

NCT06765213

22-0307

Details and patient eligibility

About

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

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 4 to 24 months old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

20 participants in 4 patient groups

Breastmilk positive/Infant sensitized

Description:

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.

Treatment:

Diagnostic Test: Open Ended Oral Food Challenge

Breastmilk positive/Infant not sensitized

Description:

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.

Treatment:

Other: Early Introduction

Breastmilk negative/Infant sensitized

Description:

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.

Treatment:

Diagnostic Test: Open Ended Oral Food Challenge

Breastmilk negative/Infant not sensitized

Description:

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.

Treatment:

Other: Early Introduction