An observational study in Food Allergy in Infants, Food Allergen Sensitisation and Breast Feeding, Exclusive, sponsored by The University of Texas Medical Branch, Galveston. Withdrawn. Open to participants aged 4 Months to 24 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-02-24.
Sponsored by The University of Texas Medical Branch, Galveston · Observational
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:
Participants will
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.
1,081 studies on the registry are indexed under Breast Feeding; 217 are open to participants now.
Browse Breast Feeding studies →The University of Texas Medical Branch, Galveston is the lead sponsor of 257 studies on the registry; 38 are open to participants now.
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Infants at 4 months of age up to 24 months of age.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Pregnant or post-partum females who plan to exclusively breastfeed and their infants who have completed at least 37 weeks of gestation
Exclusion Criteria:
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.
Diagnostic Test: Open Ended Oral Food Challenge
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.
Other: Early Introduction
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.
Diagnostic Test: Open Ended Oral Food Challenge
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.
Other: Early Introduction
Allergens determined to be sensitized will be brought in for an oral challenge to that food.
Infants that are not sensitized will have the food introduced to their diet at regular intervals.
To assess the detection of allergens in human breast milk
A mass spectrometry will be used to detect the allergens. Mass spectrometry is a technique used in the University of Texas Medical Branch (UTMB) laboratory to detect allergens.
Time frame: Baseline (4 months of age)
To assess breast milk's role in sensitization to allergens
The infant will be skin prick tested for allergens to milk, eggs, and wheat at 4 months, which is the baseline.
Time frame: Baseline (4 months of age)
Number of non-sensitized participants
The infants that are non-sensitized will begin consuming milk, eggs, and wheat, and each well child check visit.
Time frame: Baseline (4 months of age), 12 months of age, 24 months of age
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Ran from Mar 2024 to primary completion in Feb 2026, 23 months.
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This study is withdrawn, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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The University of Texas Medical Branch, Galveston →