Human Breast Milk's Role in Food Allergy Development (NCT06765213) | Clinical Trial Compass
WithdrawnNot Applicable
Human Breast Milk's Role in Food Allergy Development
Stopped: No participants enrolled
0Started 2024-03-08
Plain-language 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
Who can participate
Age range4 Months – 24 Months
SexALL
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Inclusion criteria
✓. 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.
Exclusion criteria
✕. No maternal history of atopic disease
What they're measuring
1
To assess the detection of allergens in human breast milk
Timeframe: Baseline (4 months of age)
2
To assess breast milk's role in sensitization to allergens
Timeframe: Baseline (4 months of age)
Trial details
NCT IDNCT06765213
SponsorThe University of Texas Medical Branch, Galveston