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Human Breast Milk's Role in Food Allergy Development

NCT06765213 · Status: WITHDRAWN · Type: OBSERVATIONAL

Last updated 2026-02-24

No results posted yet for this study

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

Conditions

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

Interventions

DIAGNOSTIC_TEST

Open Ended Oral Food Challenge

Allergens determined to be sensitized will be brought in for an oral challenge to that food.

OTHER

Early Introduction

Infants that are not sensitized will have the food introduced to their diet at regular intervals.

Sponsors & Collaborators

  • Texas Allergy, Asthma, and Immunology Society

    collaborator UNKNOWN

  • The University of Texas Medical Branch, Galveston

    lead OTHER

Eligibility

Min Age
4 Months
Max Age
24 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-03-08
Primary Completion
2026-02-19
Completion
2026-02-19

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06765213 on ClinicalTrials.gov