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Search / Trial NCT06765213

Human Breast Milk's Role in Food Allergy Development

Launched by THE UNIVERSITY OF TEXAS MEDICAL BRANCH, GALVESTON · Jan 2, 2025

Trial Information

Current as of July 01, 2025

Recruiting

Keywords

Food Allergy Breastmilk Allergen Testing Food Allergen Sensitization Cow Milk Allergy Egg Allergy Wheat Allergy

ClinConnect Summary

This clinical trial is studying how food allergens, like those from milk, eggs, and peanuts, might pass through breast milk to infants. The researchers want to find out if these allergens could make babies sensitive to them and possibly lead to food allergies later on. They are also exploring whether introducing certain foods early can help prevent these allergies from developing.

To participate, mothers need to be pregnant or recently have given birth, and they must plan to exclusively breastfeed their babies. The study requires mothers to provide breast milk samples, and their infants will undergo tests to check for any reactions to these allergens. This trial is particularly focused on families with a history of allergies, as they may be at a higher risk. If you meet the criteria, you can contribute to important research that could help improve understanding of food allergies in infants.

Gender

ALL

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.

About The University Of Texas Medical Branch, Galveston

The University of Texas Medical Branch (UTMB) in Galveston is a leading academic institution dedicated to advancing health through innovative research, education, and clinical care. As a prominent sponsor of clinical trials, UTMB leverages its extensive resources, multidisciplinary expertise, and commitment to excellence to facilitate groundbreaking studies that address critical health challenges. With a focus on translating scientific discoveries into effective therapies, UTMB fosters collaboration among researchers, clinicians, and participants to enhance patient outcomes and contribute to the overall advancement of medical knowledge.

Locations

League City, Texas, United States

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported