RECRUITING

Human Breast Milk's Role in Food Allergy Development

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

Evaluation of Human Breast Milk and Its Role in Early Food Allergen Sensitization in Infants

Quick Facts

Study Start:2024-03-08
Study Completion:2026-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06765213

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:4 Months to 24 Months
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. 1. Pregnant or post-partum females who plan to exclusively breastfeed and their infants who have completed at least 37 weeks of gestation
  2. 1. These are vulnerable populations
  3. 2. Our study involves breastmilk analysis, which we need postpartum mothers to supply.
  4. 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.
  5. 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.
  6. 2. Personal history of atopic disease such as allergic rhinitis/conjunctivitis, asthma, food allergies, and atopic dermatitis
  7. 3. Maternal diet must include hen's egg, cow's milk, and wheat products.
  1. 1. No maternal history of atopic disease
  2. 2. Exclusive formula feeding
  3. 3. Maternal diet devoid of hen's egg, cow's milk, or wheat, for example, vegan diets and persons with gluten sensitivity.

Contacts and Locations

Study Contact

Cleavon Covington, MD
CONTACT
409-772-0433
clcoving@utmb.edu
Joanne Acevedo, MD
CONTACT
jgaceved@utmb.edu

Study Locations (Sites)

Pediatric Sub Specialty Clinic at Bay Colony
League City, Texas, 77573
United States

Collaborators and Investigators

Sponsor: The University of Texas Medical Branch, Galveston

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-03-08
Study Completion Date2026-12

Study Record Updates

Study Start Date2024-03-08
Study Completion Date2026-12

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Food Allergy in Infants
  • Food Allergen Sensitisation
  • Breast Feeding, Exclusive
  • Breastmilk Collection